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

NCT ID: NCT03939702

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2019-07-11

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.

Conditions

Thrombosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

BMS-986177

Intervention Type: DRUG

An orally administered anticoagulant to prevent and treat thromboembolic events

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

Group Type: ACTIVE_COMPARATOR

BMS-986177

Intervention Type: DRUG

An orally administered anticoagulant to prevent and treat thromboembolic events

Interventions

BMS-986177

An orally administered anticoagulant to prevent and treat thromboembolic events

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CV010-036

Identifier Type: -

Identifier Source: org_study_id