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出境医 / 临床实验 / Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: BMS-986177 Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Non-Bile Collection
On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
 Drug: BMS-986177
An orally administered anticoagulant to prevent and treat thromboembolic events
Active Comparator: Bile Collection
On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
 Drug: BMS-986177
An orally administered anticoagulant to prevent and treat thromboembolic events
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Born male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Wisconsin
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Bristol-Myers Squibb
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE May 2, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Assess PK Cmax of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    Cmax
  • Assess PK AUC(INF) of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    AUC(INF)
  • Assess PK AUC(0-T) of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    AUC(0-T)
  • Assess PK Tmax of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    Tmax
  • Assess PK T-HALF of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    T-HALF
  • Assess PK CL/F of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
  • Assess PK Vz/F of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    Vz/F
  • Assess PK AUC of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    AUC(BMS-986177)
  • Assess PK AUC(TRA) of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    AUC(TRA)
  • Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    Plasma AUC(TRA)
  • Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    Blood AUC(TRA)
  • Assess the CLR of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    CLR
  • Assess the %UR of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    %UR
  • Assess the %FE of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    %FE
  • Assess the %BE of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    %BE (if applicable)
  • Assess the %Total recovery of [14C]BMS-986177 [ Time Frame: Day 1-12 ]
    %Total recovery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177 [ Time Frame: Day 1-12 ]
    Incidence of AEs
  • Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177 [ Time Frame: Day 1-12 ]
    Incidence of SAEs
  • 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
  • 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
  • Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177 [ Time Frame: Day 1-12 ]
    ECG physical examinations
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Official Title  ICMJE Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Thrombosis
Intervention  ICMJE Drug: BMS-986177
An orally administered anticoagulant to prevent and treat thromboembolic events
Study Arms  ICMJE
  • Active Comparator: Non-Bile Collection
    On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
    Intervention: Drug: BMS-986177
  • Active Comparator: Bile Collection
    On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
    Intervention: Drug: BMS-986177
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019) 		9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 11, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Born male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939702
Other Study ID Numbers  ICMJE CV010-036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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