Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT03596294
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2018-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C109641', 'term': 'clazosentan'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, two-period, cross-over Phase 1 study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC from zero to time t of the last measured concentration above the limit of quantification', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'AUC from zero to infinity (AUC0-inf)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'AUC from zero to 3 h (AUC0-3)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'The maximum plasma concentration (Cmax)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'Terminal half-life (t½)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'Total body clearance (CL)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}, {'measure': 'Volume of distribution at steady state (Vss)', 'timeFrame': '24 hours post treatment infusion initiation', 'description': 'The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.\n* Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.\n* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.\n* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period.\n* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.\n\nStudy-specific criteria\n\n\\- Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.\n\nExclusion Criteria:\n\n* Previous exposure to clazosentan.\n* Previous exposure to rifampicin within 3 months prior to Screening.\n* Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.\n* Known hypersensitivity or allergy to natural rubber latex.\n* Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening.\n* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.\n* Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.\n* Positive results from the HIV serology at Screening.\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': 'NCT03596294', 'briefTitle': 'A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'ID-054-106'}, 'secondaryIdInfos': [{'id': '2018-001607-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence AB', 'description': 'Period A:\n\nSaline + clazosentan\n\nPeriod B:\n\nRifampicin + clazosentan', 'interventionNames': ['Drug: Clazosentan', 'Drug: Rifampicin', 'Other: Saline (0.9% sodium chloride)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence BA', 'description': 'Period B:\n\nRifampicin + clazosentan\n\nPeriod A:\n\nSaline + clazosentan', 'interventionNames': ['Drug: Clazosentan', 'Drug: Rifampicin', 'Other: Saline (0.9% sodium chloride)']}], 'interventions': [{'name': 'Clazosentan', 'type': 'DRUG', 'description': 'Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h', 'armGroupLabels': ['Treatment sequence AB', 'Treatment sequence BA']}, {'name': 'Rifampicin', 'type': 'DRUG', 'description': 'Single i.v. dose of 600 mg rifampicin for 30 min', 'armGroupLabels': ['Treatment sequence AB', 'Treatment sequence BA']}, {'name': 'Saline (0.9% sodium chloride)', 'type': 'OTHER', 'description': 'Single i.v infusion of 500 mL saline for 30 min', 'armGroupLabels': ['Treatment sequence AB', 'Treatment sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'QPS Netherlands B.V.', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Idorsia Pharmaceuticals Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}