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Completed

NCT Number: NCT02206711

Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Male subjects
  • Ages 18-50 years
  • Body weight of at least 110 lbs (50kg)
  • BMI of 18 to 32 kg/m^2
  • non-smoking

Exclusion criteria

  • Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
  • gastrointestinal disease including gastrointestinal surgery
  • constipation or irregular bowel movements

Treatment and study plan

BMS-955176

Drug

Single dose of drug on Day 1

Primary outcomes

  1. To asses the PK (AUC, Cmax) of a single oral dose

    Time frame: Day 1 through Day 13 (predose to 288 hours)

    Serial blood samples for PK parameters determined from plasma concentration versus time

  2. To estimate extent of elimination of a single oral dose (% TRA recovery)

    Time frame: Day 1 through Day 13 (predose to 288 hours)

    Sample of urinary/fecal/bile will be collected for determining total recovery.

Secondary outcomes

  1. Safety Assessment

    Time frame: Day 1 through Day 13

    Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2014
Registry last updated
Apr 17, 2018

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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