Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01619527
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2012-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D000069547', 'term': 'Cobicistat'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-01', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of maximum plasma analyte concentration (Cmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)', 'timeFrame': 'Up to 27 Days', 'description': 'The pharmacokinetic parameter (Cmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).'}, {'measure': 'Comparison of last observed measurable analyte concentration (Clast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)', 'timeFrame': 'Up to 27 Days', 'description': 'The pharmacokinetic parameter (Clast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).'}, {'measure': 'Comparison of actual sampling time to reach the maximum plasma analyte concentration (tmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)', 'timeFrame': 'Up to 27 Days', 'description': 'The pharmacokinetic parameter (tmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) for assessment of bioequivalance.'}, {'measure': 'Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration (AUClast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)', 'timeFrame': 'Up to 27 Days', 'description': 'The pharmacokinetic parameter (AUClast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerabilty', 'timeFrame': 'Up to 27 Days', 'description': 'Safety and tolerability of darunavir/cobicistat co-administration in healthy participants will be assessed by number of participants with adverse events.'}, {'measure': 'Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet', 'timeFrame': 'Up to 27 Days', 'description': 'Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fed conditions in healthy participants will be evaluated.'}, {'measure': 'Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents', 'timeFrame': 'Up to 27 Days', 'description': 'Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fed conditions in healthy participants will be evaluated.'}, {'measure': 'Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet', 'timeFrame': 'Up to 27 Days', 'description': 'Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fasted conditions in healthy participants will be evaluated.'}, {'measure': 'Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents', 'timeFrame': 'Up to 27 Days', 'description': 'Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fasted conditions in healthy participants will be evaluated'}, {'measure': 'Evaluation of effect of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state', 'timeFrame': 'Up to 27 Days', 'description': 'Effects of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy participants', 'Darunavir', 'Cobicistat', 'Bioequivalence', 'Fixed dose combination', 'Pharmacokinetics', 'Human immunodeficiency virus', 'Protease inhibitor'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.', 'detailedDescription': 'This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants. The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs. The study consists of 3 panels. In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3). Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening\n* Have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included\n* Men and women must agree to use a highly effective method of birth control\n\nExclusion Criteria:\n\n* Has a positive HIV-1 or HIV-2 test at screening\n* Has a Hepatitis A, B or C infection (confirmed by hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody, respectively) at screening\n* Has any history of renal insufficiency\n* Has a history of significant skin reactions or any history of allergies to drugs'}, 'identificationModule': {'nctId': 'NCT01619527', 'briefTitle': 'A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen R&D Ireland'}, 'officialTitle': 'A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CR100699'}, 'secondaryIdInfos': [{'id': 'TMC114IFD1003', 'type': 'OTHER', 'domain': 'Janssen R&D Ireland'}, {'id': '2012-000273-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fasted condition)', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fasted condition).', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fed condition - standardized breakfast).', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - standardized breakfast).', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment E', 'description': 'Single-dose co-administration of the fixed dose combination darunavir/cobicistat 800/150-mg (under fasted condition).', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment F', 'description': 'Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - high-fat breakfast).', 'interventionNames': ['Drug: darunavir', 'Drug: cobicistat']}], 'interventions': [{'name': 'darunavir', 'type': 'DRUG', 'description': 'Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C', 'Treatment D', 'Treatment E', 'Treatment F']}, {'name': 'cobicistat', 'type': 'DRUG', 'description': 'Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C', 'Treatment D', 'Treatment E', 'Treatment F']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Merksem', 'country': 'Belgium', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}], 'overallOfficials': [{'name': 'Janssen R&D Ireland Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen R&D Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen R&D Ireland', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}