Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT06356194
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).', 'timeFrame': 'Day 2, Days 4-7, Days 14-17, Days 21-24', 'description': 'Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)'}, {'measure': 'To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)', 'timeFrame': 'Days 7-10, Day 12, Days 14-17, Days 21-24.', 'description': 'Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study']}, 'descriptionModule': {'briefSummary': 'Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.\n* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.\n* Willing to comply with the study requirements and to provide written informed consent.\n\nExclusion Criteria:\n\n* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.\n* Abuse of alcohol or drugs.\n* Use of other investigational drugs within 28 days of dosing.\n* Concomitant use of prescription medications, or systemic over-the-counter medications.\n* Other clinically significant medical conditions or laboratory abnormalities.'}, 'identificationModule': {'nctId': 'NCT06356194', 'briefTitle': 'Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Drug-Drug Interaction Potential Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'AT-01B-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEM/RZR vs BEM/RZR + BIK vs BIK', 'description': 'n=14', 'interventionNames': ['Drug: Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK']}, {'type': 'EXPERIMENTAL', 'label': 'BIK vs BEM/RZR + BIK vs BEM/RZR', 'description': 'n=14', 'interventionNames': ['Drug: Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered.']}], 'interventions': [{'name': 'Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK', 'type': 'DRUG', 'description': 'A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)', 'armGroupLabels': ['BEM/RZR vs BEM/RZR + BIK vs BIK']}, {'name': 'Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered.', 'type': 'DRUG', 'description': 'A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)', 'armGroupLabels': ['BIK vs BEM/RZR + BIK vs BEM/RZR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Québec', 'state': 'Montreal', 'country': 'Canada', 'facility': 'Atea Study Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}