search
Back to results

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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986177
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Thrombosis

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Covance Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non-Bile Collection

Bile Collection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assess PK Cmax of a dose of [14C]BMS-986177
Cmax
Assess PK AUC(INF) of a dose of [14C]BMS-986177
AUC(INF)
Assess PK AUC(0-T) of a dose of [14C]BMS-986177
AUC(0-T)
Assess PK Tmax of a dose of [14C]BMS-986177
Tmax
Assess PK T-HALF of a dose of [14C]BMS-986177
T-HALF
Assess PK CL/F of a dose of [14C]BMS-986177
Assess PK Vz/F of a dose of [14C]BMS-986177
Vz/F
Assess PK AUC of a dose of [14C]BMS-986177
AUC(BMS-986177)
Assess PK AUC(TRA) of a dose of [14C]BMS-986177
AUC(TRA)
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
Plasma AUC(TRA)
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
Blood AUC(TRA)
Assess the CLR of [14C]BMS-986177
CLR
Assess the %UR of [14C]BMS-986177
%UR
Assess the %FE of [14C]BMS-986177
%FE
Assess the %BE of [14C]BMS-986177
%BE (if applicable)
Assess the %Total recovery of [14C]BMS-986177
%Total recovery

Secondary Outcome Measures

Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
Incidence of AEs
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
Incidence of SAEs
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
Incidence of AEs leading to discontinuation
Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177
results of vital sign examination
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177
ECG physical examinations
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177
Results of Clinical laboratory tests

Full Information

First Posted
May 2, 2019
Last Updated
October 2, 2019
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT03939702
Brief Title
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Official Title
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Bile Collection
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bile Collection
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
BMS-986177
Intervention Description
An orally administered anticoagulant to prevent and treat thromboembolic events
Primary Outcome Measure Information:
Title
Assess PK Cmax of a dose of [14C]BMS-986177
Description
Cmax
Time Frame
Day 1-12
Title
Assess PK AUC(INF) of a dose of [14C]BMS-986177
Description
AUC(INF)
Time Frame
Day 1-12
Title
Assess PK AUC(0-T) of a dose of [14C]BMS-986177
Description
AUC(0-T)
Time Frame
Day 1-12
Title
Assess PK Tmax of a dose of [14C]BMS-986177
Description
Tmax
Time Frame
Day 1-12
Title
Assess PK T-HALF of a dose of [14C]BMS-986177
Description
T-HALF
Time Frame
Day 1-12
Title
Assess PK CL/F of a dose of [14C]BMS-986177
Time Frame
Day 1-12
Title
Assess PK Vz/F of a dose of [14C]BMS-986177
Description
Vz/F
Time Frame
Day 1-12
Title
Assess PK AUC of a dose of [14C]BMS-986177
Description
AUC(BMS-986177)
Time Frame
Day 1-12
Title
Assess PK AUC(TRA) of a dose of [14C]BMS-986177
Description
AUC(TRA)
Time Frame
Day 1-12
Title
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
Description
Plasma AUC(TRA)
Time Frame
Day 1-12
Title
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
Description
Blood AUC(TRA)
Time Frame
Day 1-12
Title
Assess the CLR of [14C]BMS-986177
Description
CLR
Time Frame
Day 1-12
Title
Assess the %UR of [14C]BMS-986177
Description
%UR
Time Frame
Day 1-12
Title
Assess the %FE of [14C]BMS-986177
Description
%FE
Time Frame
Day 1-12
Title
Assess the %BE of [14C]BMS-986177
Description
%BE (if applicable)
Time Frame
Day 1-12
Title
Assess the %Total recovery of [14C]BMS-986177
Description
%Total recovery
Time Frame
Day 1-12
Secondary Outcome Measure Information:
Title
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
Description
Incidence of AEs
Time Frame
Day 1-12
Title
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
Description
Incidence of SAEs
Time Frame
Day 1-12
Title
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
Description
Incidence of AEs leading to discontinuation
Time Frame
Day 1-12
Title
Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177
Description
results of vital sign examination
Time Frame
Day 1-12
Title
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177
Description
ECG physical examinations
Time Frame
Day 1-12
Title
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177
Description
Results of Clinical laboratory tests
Time Frame
Day 1-12

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Born male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Covance Clinical Research Unit, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs