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Completed

NCT Number: NCT02805556

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing

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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

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Lisburn, BT 28 2 RF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally healthy
  • BMI 18.0-32.0 kg/m2
  • Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
  • Men must refrain from sperm donation for the length of the study and for 90 days
  • Sign informed consent

Exclusion criteria

  • Significant medical illness
  • Tobacco use in the last 12 months
  • Major surgery within 4 weeks of study administration
  • Donation of blood within 4 weeks of study administration
  • Current or recent (within 3 months of study administration) of gastrointestinal disease

Treatment and study plan

BMS-663068

Drug

Single oral dose of BMS-663068

BMS-626529

Drug

Single intravenous dose of [13C]BMS 626529

Primary outcomes

  1. The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf)

    Time frame: up to 11 days

Secondary outcomes

  1. Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests

    Time frame: up to 31 days

  2. Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests

    Time frame: up to 31 days

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2016
Registry last updated
Jul 21, 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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