Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Phase 1
Completed
- Conditions
- Thrombosis
- Interventions
- Drug: BMS-986177
- Registration Number
- NCT03939702
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bile Collection BMS-986177 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 Non-Bile Collection BMS-986177 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
- Primary Outcome Measures
Name Time Method Assess PK Cmax of a dose of [14C]BMS-986177 Day 1-12 Cmax
Assess PK Tmax of a dose of [14C]BMS-986177 Day 1-12 Tmax
Assess PK CL/F of a dose of [14C]BMS-986177 Day 1-12 Assess PK AUC(INF) of a dose of [14C]BMS-986177 Day 1-12 AUC(INF)
Assess PK AUC(0-T) of a dose of [14C]BMS-986177 Day 1-12 AUC(0-T)
Assess PK T-HALF of a dose of [14C]BMS-986177 Day 1-12 T-HALF
Assess PK Vz/F of a dose of [14C]BMS-986177 Day 1-12 Vz/F
Assess PK AUC of a dose of [14C]BMS-986177 Day 1-12 AUC(BMS-986177)
Assess PK AUC(TRA) of a dose of [14C]BMS-986177 Day 1-12 AUC(TRA)
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177 Day 1-12 Plasma AUC(TRA)
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177 Day 1-12 Blood AUC(TRA)
Assess the CLR of [14C]BMS-986177 Day 1-12 CLR
Assess the %UR of [14C]BMS-986177 Day 1-12 %UR
Assess the %FE of [14C]BMS-986177 Day 1-12 %FE
Assess the %BE of [14C]BMS-986177 Day 1-12 %BE (if applicable)
Assess the %Total recovery of [14C]BMS-986177 Day 1-12 %Total recovery
- Secondary Outcome Measures
Name Time Method Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177 Day 1-12 Incidence of SAEs
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177 Day 1-12 Incidence of AEs
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177 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 Day 1-12 results of vital sign examination
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177 Day 1-12 ECG physical examinations
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177 Day 1-12 Results of Clinical laboratory tests
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Madison, Wisconsin, United States