A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068; Drug: Darunavir; Drug: Cobicistat

• Registration Number: NCT02277600
• Lead Sponsor: ViiV Healthcare

Brief Summary

This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Study Start: 2014-11-05
• Primary Completion: 2015-01-12
• Study Completion: 2015-01-12
• Status Verified: 2017-07
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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
• Women of childbearing potential
• Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion

Read More

Exclusion Criteria

• Any history of acute or chronic medical and surgical illness.
• Personal of family history of hemophilia A or B
• Other protocol defined exclusion criteria could apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1, Treatment A, B	BMS-663068	Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
Cohort 2, Treatment C, D	BMS-663068	Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14
Cohort 1, Treatment A, B	Darunavir	Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
Cohort 1, Treatment A, B	Cobicistat	Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
Cohort 2, Treatment C, D	Cobicistat	Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529	predose and up to 12 hours post dose on Days 4 and 14	In the presence or absence of multiple doses of DRV/COBI or COBI

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Antonio, Texas, United States