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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002706-12 | EudraCT Number |
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The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986195 | Experimental | A single oral solution dose of BMS-986195 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986195 | Drug | specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 16 days | |
| Time to attain maximum observed plasma concentration (tmax) | Up to 16 days | |
| Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)] | Up to 16 days | |
| Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)] | Up to 16 days | |
| Percentage of estimated part for the calculation of AUC0-inf (%AUCextra) | Up to 16 days | |
| Terminal elimination rate constant (kel) | Up to 16 days | |
| Terminal elimination half life, calculated as 0.693/kel (t1/2) | Up to 16 days | |
| Apparent oral clearance, calculated as dose/AUC0-inf (CL/F) | Up to 16 days | |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to 16 days | |
| Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%) | Up to 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AE) | Up to 16 days | |
| Number of serious adverse events (SAE) | Up to 16 days | |
| Number of laboratory test result abnormalities |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000710709 | branebrutinib |
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| Ratio of AUC0-inf of plasma TRA relative to blood TRA (%) | Up to 16 days |
| Cumulative amount of TRA excreted in urine (Aeurine) | Up to 16 days |
| Cumulative amount of TRA excreted in feces (Aefeces) | Up to 16 days |
| Cumulative amount of TRA excreted in bile (Aebile) | Up to 16 days |
| Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces | Up to 16 days |
| Fraction of the dose administered excreted in urine (feurine) | Up to 16 days |
| Fraction of the dose administered excreted in feces (fefeces) | Up to 16 days |
| Fraction of the dose administered excreted in bile (febile) | Up to 16 days |
| Fraction of the dose administered excreted in urine and feces (fetotal) | Up to 16 days |
| Up to 16 days |
| Heart rate measured by ECG | Up to 16 days |
| PR-interval measured by ECG | Up to 16 days |
| QRS-duration measured by ECG | Up to 16 days |
| QT-interval measured by ECG | Up to 16 days |
| QTc-interval (Fridericia's) measured by ECG | Up to 16 days |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |