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Adverse change in the risk/benefit.
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The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986421 Under Fasted Conditions | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986421 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 8 Weeks | |
| Number of participants with physical examination abnormalities | Up to 8 Weeks | |
| Number of participants with vital sign abnormalities | Up to 8 Weeks | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 8 Weeks | |
| Number of participants with clinical laboratory abnormalities | Up to 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 192 hours after each dose | |
| Area under the plasma concentration-time curve from time zero to time last quantifiable concentration (AUC[0-T]) | Up to 192 hours after each dose |
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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 | Cypress | California | 90630 | 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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| Placebo |
| Other |
Specified dose on specified days |
|
| Time of maximum observed plasma concentration (Tmax) | Up to 192 hours after each dose |