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Completed

NCT Number: NCT03939702

Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

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

  • Signed ICF
  • Healthy Male
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive.
  • Agreement to use approved contraception for 94 days post treatment
  • Agreement to not donate sperm for 94 days post treatment

Exclusion criteria

  • Acute or chronic illness
  • GI disease current or recent
  • History of dizziness or recurring headaches
  • Head injury within last 2 years
  • GI surgery
  • History or evidence of abnormal bleeding

Treatment and study plan

BMS-986177

Drug

An orally administered anticoagulant to prevent and treat thromboembolic events

Primary outcomes

  1. Assess PK Cmax of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    Cmax

  2. Assess PK AUC(INF) of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    AUC(INF)

  3. Assess PK AUC(0-T) of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    AUC(0-T)

  4. Assess PK Tmax of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    Tmax

  5. Assess PK T-HALF of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    T-HALF

  6. Assess PK CL/F of a dose of [14C]BMS-986177

    Time frame: Day 1-12

  7. Assess PK Vz/F of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    Vz/F

  8. Assess PK AUC of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    AUC(BMS-986177)

  9. Assess PK AUC(TRA) of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    AUC(TRA)

  10. Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    Plasma AUC(TRA)

  11. Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177

    Time frame: Day 1-12

    Blood AUC(TRA)

  12. Assess the CLR of [14C]BMS-986177

    Time frame: Day 1-12

    CLR

  13. Assess the %UR of [14C]BMS-986177

    Time frame: Day 1-12

    %UR

  14. Assess the %FE of [14C]BMS-986177

    Time frame: Day 1-12

    %FE

  15. Assess the %BE of [14C]BMS-986177

    Time frame: Day 1-12

    %BE (if applicable)

  16. Assess the %Total recovery of [14C]BMS-986177

    Time frame: Day 1-12

    %Total recovery

Secondary outcomes

  1. Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    Incidence of AEs

  2. Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    Incidence of SAEs

  3. Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    Incidence of AEs leading to discontinuation

  4. Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    results of vital sign examination

  5. Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    ECG physical examinations

  6. Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177

    Time frame: Day 1-12

    Results of Clinical laboratory tests

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
Oct 4, 2019

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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