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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004177-13 | EudraCT Number |
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The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165+Methotrexate+Leucovorin | Experimental | Three treatments administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Approximately 14 days | |
| Time to attain maximum observed plasma concentration (Tmax) | Approximately 14 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(0-T)] | Approximately 14 days | |
| Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)] | Approximately 14 days | |
| Terminal elimination rate constant (kel) | Approximately 14 days | |
| Terminal elimination half life, calculated as 0.693/kel (T-HALF) | Approximately 14 days | |
| Apparent oral clearance (CL/F) | Approximately 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Approximately 19 days | |
| Incidence of serious adverse events (SAEs) | Approximately 19 days |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| C000628674 | deucravacitinib |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Leucovorin | Drug | Specified dose on specified days |
|
|
| BMS-986165 | Drug | Specified dose on specified days |
|
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |