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OpenTrials
Completed

NCT Number: NCT02277600

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

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.

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-663068

Drug

BMS-663068

Darunavir

Drug

Darunavir

Cobicistat

Drug

Cobicistat

Primary outcomes

  1. Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529

    Time frame: 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 outcomes

  1. Safety as assessed by adverse events and other physical parameters

    Time frame: From dosing (Day 1) to Day 14

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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2014
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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