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Completed

NCT Number: NCT03247283

Pharmacokinetics and Metabolism Study in Healthy Male Participants

Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

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

  • Body weight 75-95kg, BMI 18.0-32.0 kg/m^2
  • Refrain from sperm donation 110 days after dosing

Exclusion criteria

  • Current or recent gastrointestinal disease
  • Any GI surgery that could impact drug absorption
  • Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986205

Drug

Carbon 14 tagged BMS-986205

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])

    Time frame: up to 28 days

    Measured by plasma concentrations

  2. Percent of Total Radioactivity Recovered in All Excreta (% total)

    Time frame: up to 28 days

    Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts

  3. Half-Life (T-HALF)

    Time frame: up to 28 days

    Measured by plasma concentrations

  4. Total Body Clearance (CLT)

    Time frame: up to 28 days

    Measured by plasma concentrations

  5. Volume of Distribution during Terminal Elimination Phase (Vz/F)

    Time frame: up to 28 days

    Measured by plasma concentrations

  6. Time to Maximum Observed Concentration (Tmax)

    Time frame: up to 28 days

    Measured by plasma concentrations

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: up to 28 days

    Measured by investigator assessment

  2. Results of electrocardiogram tests (ECGs)

    Time frame: up to 28 days

    Measured by investigator assessment

  3. Results of vital sign measurements

    Time frame: up to 28 days

    Measured by investigator assessment

  4. Results of clinical laboratory tests

    Time frame: up to 28 days

    Measured by investigator assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Pharmacokinetics and Metabolism of [14C] BMS-986205 in Healthy Male Participants

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2017
Registry last updated
Nov 6, 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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