DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Darunavir (DRV); Drug: Etravirine (ETR); Drug: BMS-663068; Drug: Ritonavir (RTV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063360

206281

AI438-020 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

Full description

Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests
• Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

Exclusion criteria

• Any significant acute or chronic medical condition
• Unable to tolerate oral medications
• Inability to be venipunctured and/or tolerate venous access
• Current or recent (within 3 months of dosing) gastrointestinal disease
• Abnormal liver function test

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Cohort 1: BMS-663068+DRV/RTV

Experimental group

Description:

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16

Treatment:

Drug: BMS-663068

Drug: Ritonavir (RTV)

Drug: Darunavir (DRV)

Cohort 2: BMS-663068+ETR

Experimental group

Description:

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16

Treatment:

Drug: BMS-663068

Drug: Etravirine (ETR)

Cohort 3: BMS-663068+DRV/RTV+ETR

Experimental group

Description:

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16

Treatment:

Drug: BMS-663068

Drug: Ritonavir (RTV)

Drug: Etravirine (ETR)

Drug: Darunavir (DRV)