Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Single Ascending Dose (SAD): Panel 1 | Experimental |
| |
| Part 1 SAD: Panel 2 | Experimental |
| |
| Part 1 SAD: Panel 3 | Experimental |
| |
| Part 1 SAD: Panel 4 | Experimental |
| |
| Part 1 SAD: Panel 5 | Experimental |
| |
| Part 1 SAD: Panel 6 | Experimental |
| |
| Part 1 SAD: Optional Split-dose Panel | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986331 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 13 months | |
| Number of participants with clinical laboratory abnormalities | Up to 46 days | |
| Number of participants with vital sign abnormalities | Up to 46 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 46 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Up to 17 days | |
| Time to reach Cmax in plasma (Tmax) | Up to 17 days | |
| Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)] |
Not provided
Inclusion Criteria:
For J-MAD Part 3
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Anaheim | California | 92801 | United States | ||
| ICON (LPRA) - Lenexa |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part 2 Multiple Ascending Dose (MAD): Panel 1 | Experimental |
|
| Part 2 MAD: Panel 2 | Experimental |
|
| Part 2 MAD: Panel 3 | Experimental |
|
| Part 2 MAD: Panel 4 | Experimental |
|
| Part 2 MAD: Optional (to be determined) Panel | Experimental |
|
| Part 3 MAD in Japanese Participants (J-MAD): Panel 1 | Experimental |
|
| Part 3 J-MAD: Panel 2 | Experimental |
|
| Part 3 J-MAD: Panel 3 | Experimental |
|
| Part 3 J-MAD: Optional (to be determined) Panel | Experimental |
|
| Placebo, Matching BMS-986331 | Other | Specified dose on specified days |
|
| Up to 17 days |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| FDA Safety Alerts and Recalls | View source |