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Completed

NCT Number: NCT02666053

A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability

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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

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.
  • Males and females
  • Women of child bearing potential (WOCBP) with negative serum or urine 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 or gastrointestinal disease
  • 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 attachment inhibitors, famotidine or high fat meal
  • History of smoking

Treatment and study plan

BMS-663068

Drug

BMS-663068

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Days 1-12

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)

    Time frame: Days 1-12

Secondary outcomes

  1. Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation

    Time frame: Days 1-12; for SAEs up to 30 days post discontinuation of dosing

    Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
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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