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The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-986419 DR Capsule - Fasted | Experimental |
| |
| Treatment B: BMS-986419 IR Tablet - Fasted | Experimental |
| |
| Treatment C: BMS-986419 IR Tablet - Fed | Experimental |
| |
| Treatment D: BMS-986419 Crushed IR Tablet - Fed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986419 DR Capsule | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 15 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to 15 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 29 days | |
| Number of participants with vital sign abnormalities | Up to 29 days | |
| Number of participants with electrocardiogram (ECG) abnormalities |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | 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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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-andpartners/ clinical-trials-andresearch/disclosure-commitment.html
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| BMS-986419 IR Tablet | Drug | Specified dose on specified days |
|
| Up to 29 days |
| Number of participants with clinical laboratory abnormalities | Up to 29 days |
| Number of participants with physical examination abnormalities | Up to 29 days |
| Time to attain maximum observed plasma concentration (Tmax) | Up to 15 days |
| Terminal half-life (T-Half) | Up to 15 days |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) | Up to 15 days |
| FDA Safety Alerts and Recalls | View source |