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The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986369, Part 1 dose escalation | Experimental |
| |
| BMS-986369 under fasted conditions, Part 2 Food effect | Experimental |
| |
| BMS-986369 under fed conditions, Part 2 Food effect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986369 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Day 1 | |
| Time of maximum observed plasma concentration (Tmax) | Day 1 | |
| Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF)) | Up to 336 hours after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | From the date of having consented until 30 days after completion of study treatment | |
| Number of participants with vital sign abnormalities | Up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Number of participants with clinical laboratory abnormalities | Up to Day 15 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 15 |
| Effect of BMS-986369 on ECG parameters - Part 1 | Up to 72 hours |