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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Darunavir
Cobicistat
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1, Treatment A, B

Cohort 2, Treatment C, D

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529
In the presence or absence of multiple doses of DRV/COBI or COBI

Secondary Outcome Measures

Full Information

First Posted
October 27, 2014
Last Updated
January 22, 2018
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02277600
Brief Title
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
Official Title
Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 5, 2014 (Actual)
Primary Completion Date
January 12, 2015 (Actual)
Study Completion Date
January 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1, Treatment A, B
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2, Treatment C, D
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Intervention Type
Drug
Intervention Name(s)
Darunavir
Intervention Description
Darunavir
Intervention Type
Drug
Intervention Name(s)
Cobicistat
Intervention Description
Cobicistat
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529
Description
In the presence or absence of multiple doses of DRV/COBI or COBI
Time Frame
predose and up to 12 hours post dose on Days 4 and 14
Other Pre-specified Outcome Measures:
Title
Safety as assessed by adverse events and other physical parameters
Description
Collection of adverse events and other physical parameters to assess safety and tolerability
Time Frame
From dosing (Day 1) to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35315687
Citation
Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.
Results Reference
derived

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

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