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The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS 986165 and Rosuvastatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed plasma concentration) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 |
| AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 |
| AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Deaths. | Measured by investigator assessment. | Up till 30 days after discontinuation |
| Number of Subjects with Serious Adverse Events. | Measured by investigator assessment. |
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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 |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin | Drug | Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin. |
|
| Up till 30 days after discontinuation |
| Number of Subjects with Adverse Events. | Measured by investigator assessment. | Up till 30 days after discontinuation |
| Number of subjects with Adverse Events Leading to Discontinuation. | Measured by investigator assessment. | Up till 30 days after discontinuation |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |