Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 10:30 PM
Study NCT ID:
NCT01989169
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Midazolam Alone', 'description': 'Administered as a single oral 20 mg dose on Day 1.', 'otherNumAtRisk': 29, 'otherNumAffected': 6, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Midazolam + SSP-004184SS', 'description': 'Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.', 'otherNumAtRisk': 30, 'otherNumAffected': 10, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'Administered as a single oral 6 mg dose on Day 1.'}, {'id': 'OG001', 'title': 'SSP-004184SS + Midazolam', 'description': 'Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '103.348', 'spread': '54.087', 'groupId': 'OG000'}, {'value': '120.1', 'spread': '38.686', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.215', 'ciLowerLimit': '1.116', 'ciUpperLimit': '1.323', 'estimateComment': 'The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.', 'groupDescription': 'The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.', 'statisticalMethod': 'Mixed-effects Model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.'}], 'paramType': 'MEAN', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'Administered as a single oral 6 mg dose on Day 1.'}, {'id': 'OG001', 'title': 'SSP-004184SS + Midazolam', 'description': 'Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.935', 'spread': '54.014', 'groupId': 'OG000'}, {'value': '116.902', 'spread': '37.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.216', 'ciLowerLimit': '1.115', 'ciUpperLimit': '1.327', 'estimateComment': 'The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.', 'groupDescription': 'The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.', 'statisticalMethod': 'Mixed-effects Model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.'}], 'paramType': 'MEAN', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'Administered as a single oral 6 mg dose on Day 1.'}, {'id': 'OG001', 'title': 'SSP-004184SS + Midazolam', 'description': 'Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.124', 'spread': '12.532', 'groupId': 'OG000'}, {'value': '48.29', 'spread': '12.605', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.383', 'ciLowerLimit': '1.282', 'ciUpperLimit': '1.491', 'estimateComment': 'The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.', 'groupDescription': 'The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.', 'statisticalMethod': 'Mixed-effects Model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.'}], 'paramType': 'MEAN', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam First', 'description': 'Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.'}, {'id': 'FG001', 'title': 'Midazolam + SSP-004184SS First', 'description': 'Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam First', 'description': 'Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.'}, {'id': 'BG001', 'title': 'Midazolam + SSP-004184SS First', 'description': 'Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '10.45', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '10.53', 'groupId': 'BG001'}, {'value': '41', 'spread': '11.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2014-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2013-11-14', 'resultsFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-16', 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Midazolam', 'timeFrame': 'Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.', 'description': 'Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal healthy male and female volunteers between the ages of 18 and 65, inclusive\n* Serum ferritin, hemoglobin and erythrocyte indices within normal range\n\nExclusion Criteria:\n\n* Evidence of any active or chronic disease'}, 'identificationModule': {'nctId': 'NCT01989169', 'briefTitle': 'Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'SPD602-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Administered as a single oral 6 mg dose on Day 1.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'SSP-004184SS + Midazolam', 'description': 'Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.', 'interventionNames': ['Drug: Midazolam', 'Drug: SSP-004184SS']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'armGroupLabels': ['Midazolam', 'SSP-004184SS + Midazolam']}, {'name': 'SSP-004184SS', 'type': 'DRUG', 'otherNames': ['SPD602'], 'armGroupLabels': ['SSP-004184SS + Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}