Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-17 @ 6:27 AM
Study NCT ID:
NCT02480894
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Open-label, Drug-Drug Interaction With Maraviroc (DDI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'C576364', 'term': 'fostemsavir'}, {'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)', 'timeFrame': 'predose and up to 12 hours post dose on Days 4, 16, 17, and 18', 'description': 'PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:\n\n\\- Cmax'}, {'measure': 'BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)', 'timeFrame': 'predose and up to 12 hours post dose on Days 4, 16, 17, and 18', 'description': 'PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:\n\n\\- AUC(TAU)'}, {'measure': 'Maraviroc Pharmacokinetics: Cmax', 'timeFrame': 'predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18', 'description': 'PK parameters for maraviroc in the absence or presence of BMS-663068 include:\n\n\\- Cmax'}, {'measure': 'Maraviroc Pharmacokinetics: AUC(TAU)', 'timeFrame': 'predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18', 'description': 'PK parameters for maraviroc in the absence or presence of BMS-663068 include:\n\n\\- AUC(TAU)'}], 'secondaryOutcomes': [{'measure': 'Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'predose and up to 12 hours post dose on Days 4, 16, 17, and 18', 'description': 'PK parameters for BMS-626529 include:\n\n\\- Tmax'}, {'measure': 'Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)', 'timeFrame': 'predose and up to 12 hours post dose on Days 4, 16, 17, and 18', 'description': 'PK parameters for BMS-626529 include:\n\n\\- C12'}, {'measure': 'Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)', 'timeFrame': 'predose and up to 12 hours post dose on Days 4, 16, 17, and 18', 'description': 'PK parameters for BMS-626529 include:\n\n\\- Ctrough (predose)'}, {'measure': 'Other PK Parameters for maraviroc: Tmax', 'timeFrame': 'predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18', 'description': 'PK Parameters for maraviroc include:\n\n-Tmax'}, {'measure': 'Other PK Parameters for maraviroc: C12', 'timeFrame': 'predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18', 'description': 'PK Parameters for maraviroc include:\n\n* C12'}, {'measure': 'Other PK Parameters for maraviroc: Ctrough', 'timeFrame': 'predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18', 'description': 'PK Parameters for maraviroc include:\n\n\\- Ctrough'}, {'measure': 'Clinical Safety as Measured by Adverse Events', 'timeFrame': 'Day 1 to Day 26', 'description': 'Adverse event monitoring'}, {'measure': 'Clinical Safety as Measured by Vital Signs', 'timeFrame': 'Day 1 to Day 26', 'description': 'Vital sign measurement'}, {'measure': 'Clinical Safety as Measured by Electrocardiograms (ECGs)', 'timeFrame': 'Day 1 to Day 26', 'description': '12-lead ECGs'}, {'measure': 'Clinical Safety as Measured by Physical Examination', 'timeFrame': 'Day 1 to Day 26', 'description': 'Physical examinations'}, {'measure': 'Clinical Safety as Measured by Clinical Laboratory Evaluations', 'timeFrame': 'Day 1 to Day 26', 'description': 'Clinical chemistry, hematology, urinalysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection, Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '35285786', 'type': 'DERIVED', 'citation': 'Wire MB, Magee M, Ackerman P, Llamoso C, Moore K. Evaluation of the pharmacokinetic drug-drug interaction between the antiretroviral agents fostemsavir and maraviroc: a single-sequence crossover study in healthy participants. HIV Res Clin Pract. 2021 Dec 9;23(1):1-8. Epub 2022 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive\n* Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* Pre-existing liver dysfunction\n* Any significant acute or chronic medical illness\n* Orthostatic intolerance\n* Other protocol specified exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT02480894', 'briefTitle': 'A Open-label, Drug-Drug Interaction With Maraviroc (DDI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects', 'orgStudyIdInfo': {'id': '206278'}, 'secondaryIdInfos': [{'id': 'AI438-052', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential Dosing', 'description': 'Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18', 'interventionNames': ['Drug: BMS-663068', 'Drug: Maraviroc']}], 'interventions': [{'name': 'BMS-663068', 'type': 'DRUG', 'description': 'BMS-663068', 'armGroupLabels': ['Sequential Dosing']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc', 'armGroupLabels': ['Sequential Dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}