Thrombosis
Conditions
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.
Interventions
DRUGBMS-986177
An orally administered anticoagulant to prevent and treat thromboembolic events
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the %Total recovery of [14C]BMS-986177 | Day 1-12 | %Total recovery |
| 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 PK Cmax of a dose of [14C]BMS-986177 | Day 1-12 | Cmax |
| 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 Tmax of a dose of [14C]BMS-986177 | Day 1-12 | Tmax |
| Assess PK T-HALF of a dose of [14C]BMS-986177 | Day 1-12 | T-HALF |
| 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177 | Day 1-12 | Incidence of AEs |
Countries
United States
Outcome results
None listed