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Completed

NCT Number: NCT02273947

Food Effect Study With BMS-955176

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

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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

Ruddington Fields, Nottinghamshire, NG11 6JS, United Kingdom

About this study

Primary Purpose

Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/[Height (m)]2
  • Men and women, ages 18 to 50 years, inclusive
  • Women must not be of childbearing potential, must not be breastfeeding

Exclusion criteria

  • Any significant acute or chronic medical illness
  • History of cardiac disease or clinically significant cardiac arrhythmias
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

Treatment and study plan

BMS-955176

Drug

Single dose by mouth for each treatment specified

Primary outcomes

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

    Time frame: Up to Day 4 of Period 4

  2. Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176

    Time frame: Up to Day 4 of Period 4

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176

    Time frame: Up to Day 4 of Period 4

  4. Plasma concentration at 24 hours post-dose (C24) for BMS-955176

    Time frame: Up to Day 4 of Period 4

Secondary outcomes

  1. Safety and tolerability

    Time frame: Up to 30 days post discontinuation of dosing

    Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Apr 17, 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.

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