Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-07 @ 2:17 PM
Study NCT ID:
NCT02841761
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2016-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C572762', 'term': 'aprocitentan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plama concentration (Cmax)', 'timeFrame': 'Midazolam PK sampling on Days 1, 2, 6 and 7', 'description': 'Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577'}, {'measure': 'Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)', 'timeFrame': 'Midazolam PK sampling on Days 1, 2, 6 and 7', 'description': 'AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577'}, {'measure': 'Time to reach Cmax (tmax)', 'timeFrame': 'Midazolam PK sampling on Days 1, 2, 6 and 7', 'description': 'Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'Midazolam PK sampling on Days 1, 2, 6 and 7', 'description': 'T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'From Day 1 to Follow-up (for up to 38 days)'}, {'measure': 'Number of subjects with serious adverse events', 'timeFrame': 'From Screening to Follow-up (for up to 59 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent in the local language prior to any study-mandated procedure\n* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening\n* Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests\n\nExclusion Criteria:\n\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol'}, 'identificationModule': {'nctId': 'NCT02841761', 'briefTitle': 'A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'AC-080-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A (Midazolam)', 'description': 'Single dose of Midazolam 8 mg on Day 1', 'interventionNames': ['Drug: Midalozam']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B1 (ACT-132577)', 'description': 'Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5.', 'interventionNames': ['Drug: Aprocitentan']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B2 (Midazolam + ACT-132577)', 'description': 'Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6', 'interventionNames': ['Drug: Midalozam', 'Drug: Aprocitentan']}], 'interventions': [{'name': 'Midalozam', 'type': 'DRUG', 'description': 'Syrup for oral use', 'armGroupLabels': ['Treatment A (Midazolam)', 'Treatment B2 (Midazolam + ACT-132577)']}, {'name': 'Aprocitentan', 'type': 'DRUG', 'otherNames': ['ACT-132577'], 'description': 'Capsules for oral use', 'armGroupLabels': ['Treatment B1 (ACT-132577)', 'Treatment B2 (Midazolam + ACT-132577)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Idorsia Pharmaceuticals Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}