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Business objectives have changed.
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The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BMS-986196 Dose 1 (Treatment A) | Experimental |
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| Part 1: BMS-986196 Dose 1 (Treatment B) | Experimental |
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| Part 2: BMS-986196 Dose 2 (Treatment A) | Experimental |
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| Part 2: BMS-986196 Dose 2 (Treatment B) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986196 | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Predose and post-dose up to Day 10 | |
| Maximum observed serum concentration (Cmax) | Predose and post-dose up to Day 10 | |
| Time of Cmax (Tmax) | Predose and post-dose up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to Day 36 | |
| Number of participants with serious AEs (SAEs) | Up to Day 36 | |
| Number of participants with vital sign abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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-and-partners/clinical-trials-and-research/disclosure-commitment.html
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| Up to Day 11 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 11 |
| Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11 | Baseline, Day 11 |
| Number of participants with physical examination findings | Up to Day 11 |
| Number of participants with clinical laboratory abnormalities | Up to Day 11 |