Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT03811834
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2019-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720862', 'term': 'mobocertinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 41)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': "Cow's milk intolerance", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '60.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of \\[14C\\]-mobocertinib intravenous in mg\\*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)\\* AUC∞ of \\[14C\\]-mobocertinib (intravenous)\\*100.', 'unitOfMeasure': 'percentage bioavailability', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This outcome measure (OM) was planned to be assessed only in Period 1.'}, {'type': 'PRIMARY', 'title': 'Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'percentage of radioactive dose', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose', 'unitOfMeasure': 'percentage of radioactive dose', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.777', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'milligram equivalent (mg eq)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '123.1', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose', 'unitOfMeasure': 'mg eq', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.061', 'spread': '0.22924', 'groupId': 'OG000'}]}]}, {'title': '12-24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7462', 'spread': '0.15716', 'groupId': 'OG000'}]}]}, {'title': '24-48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7364', 'spread': '0.12118', 'groupId': 'OG000'}]}]}, {'title': '48-72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3443', 'spread': '0.051037', 'groupId': 'OG000'}]}]}, {'title': '72-96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2173', 'spread': '0.040842', 'groupId': 'OG000'}]}]}, {'title': '96-120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1425', 'spread': '0.027883', 'groupId': 'OG000'}]}]}, {'title': '120-144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1050', 'spread': '0.021753', 'groupId': 'OG000'}]}]}, {'title': '144-168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07582', 'spread': '0.041180', 'groupId': 'OG000'}]}]}, {'title': '168-192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07517', 'spread': '0.012835', 'groupId': 'OG000'}]}]}, {'title': '192-216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05243', 'spread': '0.029772', 'groupId': 'OG000'}]}]}, {'title': '216-240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05137', 'spread': '0.029359', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose', 'unitOfMeasure': 'percentage of radioactive dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.13', 'spread': '16.772', 'groupId': 'OG000'}]}]}, {'title': '24-48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.78', 'spread': '19.584', 'groupId': 'OG000'}]}]}, {'title': '48-72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.10', 'spread': '21.089', 'groupId': 'OG000'}]}]}, {'title': '72-96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.214', 'spread': '5.3488', 'groupId': 'OG000'}]}]}, {'title': '96-120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.066', 'spread': '2.8311', 'groupId': 'OG000'}]}]}, {'title': '120-144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.638', 'spread': '1.8080', 'groupId': 'OG000'}]}]}, {'title': '144-168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.756', 'spread': '3.3943', 'groupId': 'OG000'}]}]}, {'title': '168-192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9919', 'spread': '0.83406', 'groupId': 'OG000'}]}]}, {'title': '192-216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.069', 'spread': '1.0034', 'groupId': 'OG000'}]}]}, {'title': '216-240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.695', 'spread': '1.1513', 'groupId': 'OG000'}]}]}, {'title': '240-264 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1056', 'spread': '0.14927', 'groupId': 'OG000'}]}]}, {'title': '264-288 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2216', 'spread': '0.31341', 'groupId': 'OG000'}]}]}, {'title': '288-312 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7632', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': '312-408 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3107', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': '408-432 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1143', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs', 'unitOfMeasure': 'percentage of radioactive dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '51.0', 'spread': '34.9', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '22.7', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '4.28', 'spread': '34.7', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '40.5', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '26.7', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '3.05', 'spread': '28.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '5.00'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '5.01', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '6.01'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '5.01', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '5.01'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '5.01', 'groupId': 'OG000', 'lowerLimit': '4.01', 'upperLimit': '6.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '22.8', 'spread': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '30.5', 'spread': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '14.0', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '20.5', 'spread': '25.4', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '30.9', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '12.8', 'spread': '23.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '956', 'spread': '38.6', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '486', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '73.4', 'spread': '39.9', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '729', 'spread': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '556', 'spread': '20.2', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '52.4', 'spread': '37.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '945', 'spread': '39.2', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '471', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '63.6', 'spread': '45.7', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '718', 'spread': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '543', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '45.7', 'spread': '40.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma: Mobocertinib', 'categories': [{'measurements': [{'value': '944.9', 'spread': '39.2', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32960', 'categories': [{'measurements': [{'value': '471.1', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: AP32914', 'categories': [{'measurements': [{'value': '63.61', 'spread': '45.7', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Mobocertinib', 'categories': [{'measurements': [{'value': '717.7', 'spread': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32960', 'categories': [{'measurements': [{'value': '542.8', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: AP32914', 'categories': [{'measurements': [{'value': '45.74', 'spread': '40.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1250', 'spread': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent/milliliter(ng eq/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '725', 'spread': '14.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent/ gram (ng eq/g)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-Mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '8.02', 'upperLimit': '36.0'}]}]}, {'title': 'Whole Blood', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '8.01', 'upperLimit': '36.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Plasma', 'categories': [{'measurements': [{'value': '281', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood', 'categories': [{'measurements': [{'value': '301', 'spread': '28.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '556000', 'spread': '14.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '325000', 'spread': '21.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per gram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '230300', 'spread': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '131000', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per gram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '145400', 'spread': '35.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '70190', 'spread': '32.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'nanogram equivalent*hour per gram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Mobocertinib: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001072', 'spread': '0.0010474', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 0 to 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1917', 'spread': '0.10878', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 12 to 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2047', 'spread': '0.084347', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 24 to 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1628', 'spread': '0.050589', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 48 to 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05069', 'spread': '0.029114', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 72 to 96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02087', 'spread': '0.013052', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 96 to 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01028', 'spread': '0.0052244', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 120 to 144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005860', 'spread': '0.0055472', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 144 to 168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002438', 'spread': '0.0014131', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 168 to 192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0009682', 'spread': '0.0011637', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 192 to 216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0009890', 'spread': '0.00090295', 'groupId': 'OG000'}]}]}, {'title': 'Mobocertinib: 216 to 240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0002824', 'spread': '0.00063158', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005308', 'spread': '0.0045461', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 0-12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2948', 'spread': '0.078117', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 12-24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2199', 'spread': '0.056834', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 24-48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2166', 'spread': '0.049030', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 48-72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09444', 'spread': '0.020647', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 72-96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05401', 'spread': '0.014311', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 96-120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03017', 'spread': '0.0070669', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 120-144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01764', 'spread': '0.0068670', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 144-168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01082', 'spread': '0.0028229', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 168-192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007272', 'spread': '0.0023649', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 192-216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005427', 'spread': '0.0021935', 'groupId': 'OG000'}]}]}, {'title': 'AP32960: 216-240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004235', 'spread': '0.0016891', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 0-12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08336', 'spread': '0.022896', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 12-24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06029', 'spread': '0.015305', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 24-48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04953', 'spread': '0.021338', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 48-72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01543', 'spread': '0.0068257', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 72-96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005859', 'spread': '0.0040117', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 96-120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002477', 'spread': '0.0016606', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 120-144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0008353', 'spread': '0.0010134', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 144-168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0001780', 'spread': '0.00043613', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 168-192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 192-216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'AP32914: 216-240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'Mobocertinib', 'categories': [{'measurements': [{'value': '0.657', 'spread': '44.3', 'groupId': 'OG000'}]}]}, {'title': 'AP32960', 'categories': [{'measurements': [{'value': '1.95', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'AP32914', 'categories': [{'measurements': [{'value': '2.85', 'spread': '27.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose', 'unitOfMeasure': 'liter per hour ( L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.'}, {'type': 'PRIMARY', 'title': 'Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'title': 'At 0.5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.022', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'At 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9851', 'spread': '36.0', 'groupId': 'OG000'}]}]}, {'title': 'At 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9055', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'At 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8403', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'At 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8221', 'spread': '23.3', 'groupId': 'OG000'}]}]}, {'title': 'At 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8545', 'spread': '17.2', 'groupId': 'OG000'}]}]}, {'title': 'At 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7647', 'spread': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'At 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7634', 'spread': '20.7', 'groupId': 'OG000'}]}]}, {'title': 'At 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7573', 'spread': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'At 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8139', 'spread': '23.0', 'groupId': 'OG000'}]}]}, {'title': 'At 36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7028', 'spread': '13.2', 'groupId': 'OG000'}]}]}, {'title': 'At 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7113', 'spread': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'At 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6453', 'spread': '18.8', 'groupId': 'OG000'}]}]}, {'title': 'At 96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6164', 'spread': '18.0', 'groupId': 'OG000'}]}]}, {'title': 'At 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6260', 'spread': '13.2', 'groupId': 'OG000'}]}]}, {'title': 'At 144 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5946', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'At 168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 192 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 216 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 240 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. Here, \'0\' in the number analyzed field signifies that no participants were evaluable at specified time points. This OM was planned to be assessed only in Period 2.'}, {'type': 'SECONDARY', 'title': 'Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously over 15 minutes, once on Day 1 of Period 1.'}], 'classes': [{'title': '[14C]-Mobocertinib', 'categories': [{'measurements': [{'value': '146.3', 'spread': '46.4', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32960', 'categories': [{'measurements': [{'value': '1.842', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32914', 'categories': [{'measurements': [{'value': '2.432', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'picograms per milliliter (pg /mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': 'Mobocertinib', 'categories': [{'measurements': [{'value': '56.7', 'spread': '52.2', 'groupId': 'OG000'}]}]}, {'title': 'AP32960', 'categories': [{'measurements': [{'value': '23.29', 'spread': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'AP32914', 'categories': [{'measurements': [{'value': '4.086', 'spread': '36.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': '[14C]-mobocertinib', 'categories': [{'measurements': [{'value': '148', 'spread': '44.0', 'groupId': 'OG000'}]}]}, {'title': '[14C]-AP32960', 'categories': [{'measurements': [{'value': '6.631', 'spread': '76.4', 'groupId': 'OG000'}]}]}, {'title': '[14C]-AP32914', 'categories': [{'measurements': [{'value': '3.772', 'spread': '33.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': 'Mobocertinib', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': 'AP32960', 'categories': [{'measurements': [{'value': '4.502', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': 'AP32914', 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': '[14C]-mobocertinib', 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '1.25'}]}]}, {'title': '[14C]- AP32960', 'categories': [{'measurements': [{'value': '3.257', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '8.26'}]}]}, {'title': '[14C]- AP32914', 'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000', 'lowerLimit': '2.26', 'upperLimit': '2.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for \\[14C\\]-mobocertinib and its metabolites (\\[14C\\]-AP32960 and \\[14C\\]-AP32914) is reported following intravenous administration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': 'Mobocertinib', 'categories': [{'measurements': [{'value': '1050', 'spread': '64.9', 'groupId': 'OG000'}]}]}, {'title': 'AP32960', 'categories': [{'measurements': [{'value': '478.2', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'AP32914', 'categories': [{'measurements': [{'value': '73.02', 'spread': '53.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': '[14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '680', 'spread': '30.4', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32960', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '187.8', 'spread': '60.2', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32914', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.71', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'picogram*hour/ milliliter (pg*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': 'Mobocertinib', 'categories': [{'measurements': [{'value': '1032', 'spread': '65.6', 'groupId': 'OG000'}]}]}, {'title': 'AP32960', 'categories': [{'measurements': [{'value': '461.2', 'spread': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'AP32914', 'categories': [{'measurements': [{'value': '66.92', 'spread': '53.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': '[14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '617.9', 'spread': '34.0', 'groupId': 'OG000'}]}]}, {'title': '[14C]-AP32960', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '133.1', 'spread': '63.1', 'groupId': 'OG000'}]}]}, {'title': '[14C]-AP32914', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.52', 'spread': '113.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': '[14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '617.9', 'spread': '34.0', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32960', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '133.1', 'spread': '63.1', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32914', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.52', 'spread': '113.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'unitOfMeasure': 'picogram*hour per milliliter (pg*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}], 'classes': [{'title': 'Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.9', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'AP32960', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.077', 'spread': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'AP32914', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.545', 'spread': '37.5', 'groupId': 'OG000'}]}]}, {'title': '[14C]-Mobocertinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '41.3', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32960', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.317', 'spread': '39.1', 'groupId': 'OG000'}]}]}, {'title': '[14C]- AP32914', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.900', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be calculated because single participant was analyzed.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for \\[14C\\]-mobocertinib and its metabolites (\\[14C\\]-AP32960 and \\[14C\\]-AP32914) is reported following intravenous administration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}, {'id': 'OG001', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}, {'id': 'OG001', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}, {'id': 'OG001', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.'}, {'id': 'OG001', 'title': '[14C]-Mobocertinib 160 mg', 'description': '\\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 microcurie \\[mcCi\\]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by \\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'periods': [{'title': 'Period 1 ( 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout Period (9 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (10 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United States from 22 January 2019 to 11 March 2019.', 'preAssignmentDetails': 'Healthy male participants were enrolled in this 2-period study to receive mobocertinib 160 milligram (mg), capsules followed by carbon-14 \\[14C\\]-mobocertinib 50 microgram (mcg), infusion in Period 1 (Absolute Bioavailability \\[ABA\\]) and \\[14C\\]-mobocertinib 160 mg, solution in Period 2 (Absorption, Distribution, Metabolism, and Elimination \\[ADME\\]).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg +[14C]-Mobocertinib 160 mg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by \\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '12.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.74', 'spread': '6.141', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (Kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '175.9', 'spread': '4.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.079', 'spread': '1.6520', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety set included all participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-27', 'size': 3129656, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-10T09:24', 'hasProtocol': True}, {'date': '2019-08-08', 'size': 2879558, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-10T09:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2019-01-18', 'resultsFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-09', 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of \\[14C\\]-mobocertinib intravenous in mg\\*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)\\* AUC∞ of \\[14C\\]-mobocertinib (intravenous)\\*100.'}, {'measure': 'Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose'}, {'measure': 'Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose'}, {'measure': 'Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib', 'timeFrame': 'Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose'}, {'measure': 'Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib', 'timeFrame': 'Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs'}, {'measure': 'Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose'}, {'measure': 'Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose'}, {'measure': 'Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)', 'timeFrame': 'At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose'}], 'secondaryOutcomes': [{'measure': 'Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for \\[14C\\]-mobocertinib and its metabolites (\\[14C\\]-AP32960 and \\[14C\\]-AP32914) is reported following intravenous administration.'}, {'measure': 'Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose'}, {'measure': 'Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose', 'description': 'Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for \\[14C\\]-mobocertinib and its metabolites (\\[14C\\]-AP32960 and \\[14C\\]-AP32914) is reported following intravenous administration.'}, {'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Values', 'timeFrame': 'Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '38789848', 'type': 'DERIVED', 'citation': 'Hanley MJ, Zhang S, Griffin R, Zhu SX, Fram RJ, Lin J, Venkatakrishnan K, Gupta N. A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [14C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Invest New Drugs. 2024 Aug;42(4):343-352. doi: 10.1007/s10637-024-01446-y. Epub 2024 May 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine:\n\nPeriod 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie \\[mcCi\\]) \\[14 C\\]-\\]-mobocertinib and single oral administration of 160 milligram (mg) mobocertinib.\n\nPeriod 2 (absorption, distribution, metabolism, and elimination \\[ADME\\]): the mass balance and metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 160 mg (approximately 100 mcCi) \\[14C\\]-mobocertinib solution.', 'detailedDescription': 'The drug being tested in this study is called mobocertinib. The study will determine ABA of mobocertinib following single microdose of 50 mcg \\[14C\\]-mobocertinib and single oral administration of 160 mg mobocertinib and will assess the mass balance and metabolic profile of mobocertinib in plasma, urine, and feces following a single oral administration of 160 mg \\[14C\\]-mobocertinib solution, and will characterize the PK of mobocertinib and its metabolites in plasma, whole blood, and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single dose of 160 mg \\[14C\\]-mobocertinib.\n\nThe study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1, all participants will receive single unlabeled oral 160 mg dose of mobocertinib as capsules. At 3.75 hours post oral dosing, participants will receive 15-minute intravenous infusion of a microdose of 50 mcg (approximately 2mcCi) \\[14C\\]-mobocertinib. In Period 2, participants will receive single dose of 160 mg (approximately 100 mcCi) \\[14C\\]-mobocertinib as an oral solution.\n\nThis single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Continuous non smoker who has not used nicotine containing products for at least 20 years prior to the first dosing and throughout the study, based on subject self-reporting.\n2. Body mass index greater than or equal to (\\>=)18 and less than (˂) 30.0 kilogram per square meter (kg/m\\^2) at screening.\n\nExclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.\n3. Has positive urine drug or alcohol results at screening or first check in.\n4. Estimated creatinine clearance \\< 80 milliliter per minute (mL/min) at screening.\n5. Has tattoo(s) or scarring at or near the site of intravenous (IV) infusion or any other condition which may interfere with infusion site examination, in the opinion of the investigator.\n6. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.\n7. Has recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.\n8. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is., weighted annual limit recommended by the Commission on Radiological Protection \\[ICRP\\] of 3000 millirem).\n9. Donation of blood or significant blood loss within 56 days prior to the first dosing.\n10. Plasma donation within 7 days prior to the first dosing.'}, 'identificationModule': {'nctId': 'NCT03811834', 'briefTitle': 'A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1 Study to Assess Absolute Bioavailability of TAK-788 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-788 in Male Healthy Subjects', 'orgStudyIdInfo': {'id': 'TAK-788-1002'}, 'secondaryIdInfos': [{'id': 'U1111-1223-7593', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg', 'description': 'Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by \\[14C\\]-mobocertinib 50 mcg (approximately 2 microcurie \\[mcCi\\]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by \\[14C\\]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.', 'interventionNames': ['Drug: Mobocertinib']}], 'interventions': [{'name': 'Mobocertinib', 'type': 'DRUG', 'otherNames': ['TAK-788'], 'description': 'Mobocertinib capsule, \\[14C\\]-Mobocertinib intravenous infusion, \\[14C\\]-Mobocertinib oral solution.', 'armGroupLabels': ['Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}