Skip to main content
OpenTrials
Completed

NCT Number: NCT03004768

Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Madison Clinical Research Unit

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

  • Signed Informed Consent
  • Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
  • Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
  • No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination

Exclusion criteria

  • History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
  • Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
  • Participant with greater than Grade 2 acne.
  • Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

Treatment and study plan

BMS-986165

Drug

Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA

Primary outcomes

  1. The primary endpoint is PK exposure that will be determined from plasma concentration versus time

    Time frame: Day 1 to Day 13

  2. Urinary/fecal TRA (Total radioactivity) recovery data

    Time frame: Day 1 to Day 13

  3. PK terminal elimination half-life data (T-HALF)

    Time frame: Day 1 to Day 13

  4. PK apparent total body clearance (CL/F)

    Time frame: Day 1 to Day 13

  5. PK apparent volume of distribution (Vz/F)

    Time frame: Day 1 to Day 13

  6. PK time of maximum observed plasma concentration (Tmax)

    Time frame: Day 1 to Day 13

Secondary outcomes

  1. Safety endpoints include the incidence of adverse events (AEs)

    Time frame: Day 1 to Day 13

  2. Safety endpoints include the results of electrocardiogram tests (ECGs)

    Time frame: Day 1 to Day 13

  3. Safety endpoints include the results of vital signs

    Time frame: Day 1 to Day 13

  4. Safety endpoints include the results of physical exams

    Time frame: Day 1 to Day 13

  5. Safety endpoints include the results of clinical laboratory tests

    Time frame: Day 1 to Day 13

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Covance

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2016
Registry last updated
Feb 12, 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.

Published trials that share one or more normalized conditions with this study.