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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Bile Collection | Active Comparator | 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 |
|
| Bile Collection | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug | An orally administered anticoagulant to prevent and treat thromboembolic events |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Born male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000720754 | milvexian |
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| 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 |
| 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 |