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The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A | Experimental |
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| Cohort 1B | Experimental |
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| Cohort 1C | Experimental |
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| Cohort 2A | Experimental |
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| Cohort 2B | Experimental |
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| Cohort 2C | Experimental |
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| Cohort 2D | Experimental |
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| Cohort 3A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986368 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 44 days | |
| Number of participants with serious adverse events (SAEs) | Up to 44 days | |
| Number of participants with vital sign (VS) abnormalities | Up to 21 days | |
| Number of participants with physical examination abnormalities | Up to 21 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 21 days | |
| Number of participants with clinical laboratory asssement abnormalities | Up to 21 days | |
| Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | Up to 16 days | |
| Maximum observed plasma concentration (Cmax) | Up to 16 days | |
| Time of maximum observed plasma concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Anaheim | California | 92780 | 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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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer 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
See plan description
See plan description
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| Cohort 3B | Experimental |
|
| Up to 16 days |
| Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days |
| Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days |
| Plasma concentrations of anandamide (AEA) | Up to 21 days |
| Percent change from baseline of anandamide (AEA) | Up to 21 days |
| Whole blood concentrations of 2-arachidonoylglycerol (2-AG) | Up to 21 days |
| Percent change from baseline of 2-arachidonoylglycerol (2-AG) | Up to 21 days |