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Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: BMS-986165 Dose 1 | Experimental | Participants will receive Dose 1 on Day 1, and from Day 5 - 19. |
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| Group 2: BMS-986165 Dose 2 | Experimental | Participants will receive Dose 2 on Day 1, and from Day 5 - 19. |
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| Group 1: Placebo Dose 1 | Placebo Comparator | Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19. |
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| Group 2: Placebo Dose 2 | Placebo Comparator | Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Dose 1 or Dose 2 on Day 1, and from Days 5-19' |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165 | Day 1 to Day 4 | |
| Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Apparent Oral Total Body Clearance (CLT/F) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF]) | Day 1 to Day 4 | |
| Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax) | Days 1 to 4, Day 5, and Day 19 | |
| Apparent Volume of Distribution (Vz/F) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 | |
| Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 31 | |
| Number of Participants With Clinically Significant Change in Clinical Laboratory Values | Up to Day 24 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37981596 | Derived | Jing S, Lin Y, Dockens R, Marchisin D, He B, Girgis IG, Chimalakonda A, Murthy B, Aras U. Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Dermatol Ther (Heidelb). 2023 Dec;13(12):3153-3164. doi: 10.1007/s13555-023-01050-7. Epub 2023 Nov 19. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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 |
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There will be two dose groups. Once the safety and tolerability up to discharge (Day 24) of Group 1, has been assessed and deemed safe; dosing for Group 2 will begin.
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| Placebo | Other | Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19 |
|
| Day 5 to Day 19 |
| Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165 | Day 5 and Day 19 |
| Effective Elimination Half-Life (T-HALFeff) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 |
| Trough Observed Plasma Concentration (Ctrough) of BMS-986165 | Day 2 to 20 |
| Average Plasma Concentration at Steady State (Css-avg) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 |
| Accumulation Index (AI) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 |
| Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU]) | Day 5 to Day 19 |
| Degree of Fluctuation (DF) of BMS-986165 | Days 1 to 4, Day 5, and Day 19 |
| Number of Participants With Clinically Significant Change in Vital Signs |
| Up to Day 24 |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) | Up to Day 24 |
| Number of Participants With Clinically Significant Change in Physical Examination | Up to Day 24 |
| Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170 | Days 1 to 4, Day 5, and Day 19 |
| Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165 | Day 1 to Day 5 |
| Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165 | Day 1 to Day 5 |
| Renal Clearance (CLR) Following Single Oral Doses of BMS-986165 | Day 1 to Day 5 |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |