Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT03295266
Status:
TERMINATED
Last Update Posted:
2019-11-13
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days', 'description': 'All treated participants are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '41.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.', 'unitOfMeasure': 'hour*µM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '57.9', 'spread': '42.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.', 'unitOfMeasure': 'hour*µM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '34.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose', 'description': 'AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.', 'unitOfMeasure': 'hour*µM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Concentration at the End of Infusion (Ceoi) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '30.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.5 (end of infusion) hours postdose', 'description': 'The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.', 'unitOfMeasure': 'µM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Concentration (Tmax) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.53'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Tmax is the time at which the maximum plasma drug concentration is detected.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.54', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '4.16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Apparent t1/2 is the elimination half-life of MK-3866 from plasma.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Clearance (CL) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.16', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '41.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'CL is the volume of plasma from which the study drug is completely removed per unit time.', 'unitOfMeasure': 'Liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution (Vz) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '27.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Vz is the apparent volume of distribution during the terminal phase.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with data available are included.'}, {'type': 'SECONDARY', 'title': 'Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'timeFrame': 'Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose', 'description': 'Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Urine samples were collected but were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLr) of MK-3866', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'timeFrame': 'Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose', 'description': 'CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Urine samples were collected but were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued the Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'OG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'FG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study terminated prior to enrollment of any healthy control participants.', 'preAssignmentDetails': 'Participants with moderate or severe hepatic impairment (HI) based on estimated glomerular filtration rate (eGFR) were enrolled at 2 study centers in the US.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (eGFR of ≤60mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'BG001', 'title': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '5.96', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '7.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-06', 'size': 748719, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-22T08:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Business and program changes', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2017-09-25', 'resultsFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-22', 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.'}, {'measure': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.'}, {'measure': 'Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose', 'description': 'AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.'}, {'measure': 'Concentration at the End of Infusion (Ceoi) of MK-3866', 'timeFrame': '0.5 (end of infusion) hours postdose', 'description': 'The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.'}, {'measure': 'Time to Maximum Concentration (Tmax) of MK-3866', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Tmax is the time at which the maximum plasma drug concentration is detected.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-3866', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Apparent t1/2 is the elimination half-life of MK-3866 from plasma.'}, {'measure': 'Clearance (CL) of MK-3866', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'CL is the volume of plasma from which the study drug is completely removed per unit time.'}, {'measure': 'Volume of Distribution (Vz) of MK-3866', 'timeFrame': 'Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose', 'description': 'Vz is the apparent volume of distribution during the terminal phase.'}], 'secondaryOutcomes': [{'measure': 'Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)', 'timeFrame': 'Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose', 'description': 'Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.'}, {'measure': 'Renal Clearance (CLr) of MK-3866', 'timeFrame': 'Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose', 'description': 'CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.'}, {'measure': 'Number of Participants With at Least One Adverse Event (AE)', 'timeFrame': 'Up to 14 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Number of Participants Who Discontinued the Study Due to an AE', 'timeFrame': 'Up to 14 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Insufficiency', 'Antibacterial Agents']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy participants. The primary purpose of this study is to understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing recommendations for participants with HI. This study will also evaluate the safety and tolerability of MK-3866 in participants with moderate and severe HI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index ≥19 \\& ≤40 kg/m\\^2\n* Continuous non-smoker prior to screening \\& enrollment\n* HI Participants: Baseline health judged to be stable based on medical history (except for the HI condition), physical examination, vital signs, electrocardiograms, \\& laboratory safety tests\n* Healthy control participants: Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms\n* HI Participants: Diagnosis of chronic (\\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) HI with features of cirrhosis\n* HI Participants - Panel A (moderate HI) only: score on the Child-Pugh scale from 7 to 9 (moderate HI). At least 3 participants must have a score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, international normalized ratio, and/or bilirubin) on the Child-Pugh scale\n* HI Participants - Panel B (severe HI) only: Score on the Child-Pugh scale from 10 to 15 (severe HI)\n* Is completely informed of the unknown risks of pregnancy \\& agrees not to become pregnant or father a child during time in study\n* For a female of childbearing potential: is either sexually inactive (abstinent) for 14 days prior to dosing \\& throughout the study or is using an acceptable birth control method\n* Non-vasectomized male: Participants must agree to use a condom with spermicide or abstain from sexual intercourse from dosing until 90 days after dosing\n\nExclusion Criteria:\n\n* Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study\n* Has a history or presence of clinically significant medical or psychiatric condition or disease (other than HI - Panels A \\& B) that might confound the results of the study or poses an additional risk to the participant. Remote history of cholecystectomy that is not an active issue may be included.\n* Panels A \\& B: Has a clinically significant history of cancer. Remote history with full cure or limited disease with complete resection (cure) may be included\n* Has a history of drug/alcohol abuse within the past 6 months prior to dosing (Panels A \\& B) or within the past 2 years prior to dosing (Panel C \\[Healthy controls\\])\n* Panels A \\& B: Consumes more than 3 glasses of alcoholic beverages (1 glass approximately equivalent to: beer \\[354 mL/12 ounces\\], wine \\[118 mL/4 ounces\\], or distilled spirits \\[29.5 mL/1 ounce\\]) per day, within 6 months of screening. Participants that consume 4 glasses of alcoholic beverages/day may be enrolled\n* Panels A \\& B: Consumes excessive amounts, defined as more than 6 servings (1 serving approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy-drinks, or other caffeinated beverages/day\n* Panels A \\& B: Has a history of a liver transplant\n* Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds\n* Has moderate or severe renal insufficiency (estimated glomerular filtration rate of ≤60 mL/min/1.73 m2 for moderate HI or healthy control participants or ≤50 mL/min/1.73 m2 for severe HI participants)\n* Panel C: Has positive macroscopic urine protein at screening (trace protein by dipstick allowed)\n* Is a female participant who is pregnant or lactating\n* Has positive results for the urine or breath alcohol screen and/or urine drug screen at screening\n* Has positive results at screening for human immunodeficiency virus (HIV) (Panels A \\& B) or for HIV, HBsAg, or hepatitis C virus (HCV) (Panel C)\n* Panels A \\& B: Participants with active HCV infection or hepatitis B virus (HBV) infection. Participants with prior/inactive HCV infection or past HBV infection may be enrolled.\n* Is unable to refrain from or anticipates use of any medication or substance prohibited in study\n* Has taken amiodarone at any time in their life'}, 'identificationModule': {'nctId': 'NCT03295266', 'briefTitle': 'Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3866 When Administered to Subjects With Moderate and Severe Hepatic Impairment', 'orgStudyIdInfo': {'id': '3866-006'}, 'secondaryIdInfos': [{'id': 'MK-3866-006', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment (Panel A)', 'description': 'Participants with moderate HI (estimated glomerular filtration rate \\[eGFR\\] of ≤60mL/min/1.73m\\^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.', 'interventionNames': ['Drug: MK-3866']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment (Panel B)', 'description': 'Participants with severe HI (eGFR of ≤50 mL/min/1.73m\\^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.', 'interventionNames': ['Drug: MK-3866']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Matched Controls (Panel C)', 'description': 'Healthy participants receive a single IV dose of MK-3866 (150 mg) on Day 1.', 'interventionNames': ['Drug: MK-3866']}], 'interventions': [{'name': 'MK-3866', 'type': 'DRUG', 'description': 'Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.', 'armGroupLabels': ['Healthy Matched Controls (Panel C)', 'Moderate Hepatic Impairment (Panel A)', 'Severe Hepatic Impairment (Panel B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami ( Site 0001)', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center ( Site 0002)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}