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

Bristol-Myers Squibb9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Thrombosis

Interventions

BMS-986177DRUG

An orally administered anticoagulant to prevent and treat thromboembolic events

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Cmax

Time frame: Day 1-12

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

AUC(INF)

Time frame: Day 1-12

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

AUC(0-T)

Time frame: Day 1-12

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

Tmax

Time frame: Day 1-12

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

T-HALF

Time frame: Day 1-12

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

Vz/F

Time frame: Day 1-12

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

AUC(BMS-986177)

Time frame: Day 1-12

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

AUC(TRA)

Time frame: Day 1-12

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

Plasma AUC(TRA)

Time frame: Day 1-12

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Incidence of AEs

Time frame: Day 1-12

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

Incidence of SAEs

Time frame: Day 1-12

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

Time frame: Day 1-12

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

results of vital sign examination

Time frame: Day 1-12

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

ECG physical examinations

Time frame: Day 1-12

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

Results of Clinical laboratory tests

Time frame: Day 1-12