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The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Dose 1 |
| |
| Ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 | Day 1 | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 | Day 1 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 | Day 1 | |
| Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir | Day 15 | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir | Day 15 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | initial dose up to day 29 | |
| vital signs of blood pressure | initial dose up to day 29 | |
| Vital signs of body temperature |
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Inclusion Criteria:
Exclusion Criteria:
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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 - Salt Lake | Salt Lake City | Utah | 84124 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Drug |
100 mg |
|
| initial dose up to day 29 |
| Vital signs of respiratory rate | initial dose up to day 29 |
| Number of Clinically significant changes in lab assessment of blood serum | initial dose up to day 29 |
| Number of Clinically significant changes in the lab assessment of blood | initial dose up to day 29 |
| Number of Clinically significant changes in the lab assessment of urine | initial dose up to day 29 |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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