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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02277600
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-663068; Drug: Darunavir; Drug: Cobicistat	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects
• Actual Study Start Date: Nov 5, 2014
• Actual Primary Completion Date: Jan 12, 2015
• Actual Study Completion Date: Jan 12, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1, Treatment A, B 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	Drug: BMS-663068; BMS-663068; Drug: Darunavir; Darunavir; Drug: Cobicistat; Cobicistat
Experimental: Cohort 2, Treatment C, D 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	Drug: BMS-663068; BMS-663068; Drug: Cobicistat; Cobicistat

Outcome Measures

Primary Outcome Measures

1. 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

Other Outcome Measures

1. Safety as assessed by adverse events and other physical parameters [From dosing (Day 1) to Day 14]

   Collection of adverse events and other physical parameters to assess safety and tolerability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02277600
• Other Study ID Numbers: 206285; AI438-044
• First Posted: Oct 29, 2014
• Last Update Posted: Jan 24, 2018
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Darunavir; Cobicistat; Fostemsavir

Study Results

No Results Posted as of Jan 24, 2018