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The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet-Capsule Crossover 1 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
|
| Tablet-Capsule Crossover 2 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
|
| Tablet-Capsule Crossover 3 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
|
| Tablet-Capsule Crossover 4 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
|
| Tablet-Capsule Crossover 5 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 Capsule | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time | 5 days | |
| AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time | 5 days | |
| Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time | 5 days | |
| Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events measured by incidence | 26 days | |
| Serious adverse events measured by incidence | Approximately 55 days |
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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 | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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|
| Tablet-Capsule Crossover 6 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
|
| BMS-986165 Tablet | Drug | Oral tablet |
|
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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