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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: BMS-986177


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Bile Collection<br>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<br>* An orally administered anticoagulant to prevent and treat thromboembolic events<br>|
| Active Comparator: Bile Collection<br>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<br>* An orally administered anticoagulant to prevent and treat thromboembolic events<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess PK Cmax of a dose of [14C]BMS-986177 | Cmax | Day 1-12 | 
| Assess PK AUC(INF) of a dose of [14C]BMS-986177 | AUC(INF) | Day 1-12 | 
| Assess PK AUC(0-T) of a dose of [14C]BMS-986177 | AUC(0-T) | Day 1-12 | 
| Assess PK Tmax of a dose of [14C]BMS-986177 | Tmax | Day 1-12 | 
| Assess PK T-HALF of a dose of [14C]BMS-986177 | T-HALF | Day 1-12 | 
| Assess PK CL/F of a dose of [14C]BMS-986177 |  | Day 1-12 | 
| Assess PK Vz/F of a dose of [14C]BMS-986177 | Vz/F | Day 1-12 | 
| Assess PK AUC of a dose of [14C]BMS-986177 | AUC(BMS-986177) | Day 1-12 | 
| Assess PK AUC(TRA) of a dose of [14C]BMS-986177 | AUC(TRA) | Day 1-12 | 
| Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177 | Plasma AUC(TRA) | Day 1-12 | 
| Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177 | Blood AUC(TRA) | Day 1-12 | 
| Assess the CLR of [14C]BMS-986177 | CLR | Day 1-12 | 
| Assess the %UR of [14C]BMS-986177 | %UR | Day 1-12 | 
| Assess the %FE of [14C]BMS-986177 | %FE | Day 1-12 | 
| Assess the %BE of [14C]BMS-986177 | %BE (if applicable) | Day 1-12 | 
| Assess the %Total recovery of [14C]BMS-986177 | %Total recovery | Day 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177 | Incidence of AEs | Day 1-12 | 
| Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177 | Incidence of SAEs | 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 | 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 | Day 1-12 | 
| Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177 | ECG physical examinations | Day 1-12 | 
| Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177 | Results of Clinical laboratory tests | Day 1-12 |