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Completed

NCT Number: NCT02095886

Relative Bioavailability Study With BMS-955176

The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

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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

Nottingham, NG11 6JS, United Kingdom

About this study

Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (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

BMS-955176

Primary outcomes

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

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

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

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

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

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax) of BMS-955176

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

  2. Terminal plasma half-life (T-HALF) of BMS-955176

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

  3. Apparent total body clearance (CLT/F) of BMS-955176

    Time frame: Days 1-4 of Periods 1, 2, 3 and 4

  4. Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations

    Time frame: Up to Period 4/Day 4 (discharge)

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Sep 11, 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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