Skip to main content
OpenTrials
Completed

NCT Number: NCT02715479

A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176

Completed

Looking for future studies?

Notify Me

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

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed Informed Consent
  • Target population: Healthy males and females.
  • Women of child bearing potential (WOCBP) with negative serum pregnancy test
  • Women must not be breastfeeding
  • Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

  • History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
  • History of frequent headaches or acute diarrhoea.
  • Any major surgery within 4 weeks of study drug administration
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
  • History of allergy to HIV maturation and integrase inhibitors,or related compounds
  • History of smoking

Treatment and study plan

Dolutegravir

Drug

Dolutegravir

BMS955176

Drug

BMS955176

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) for DTG

    Time frame: Days 1 to 5 and days 15 to 21

  2. Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG

    Time frame: Days 1 to 5 and days 15 to 21

  3. Maximum observed plasma concentration (Cmax) for BMS-955176

    Time frame: Days 8-21

  4. Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176

    Time frame: Days 8-21

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Days 1-21; for SAEs up to 30 days post discontinuation of dosing

    The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 22, 2016
Registry last updated
Jan 19, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.