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The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-986435 Reference Dose 1 | Active Comparator |
| |
| Treatment B: BMS-986435 Test Dose 1 | Experimental |
| |
| Treatment C: BMS-986435 Test Dose 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986435 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 105 days | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] | Up to 105 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to 105 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)] | Up to 105 days | |
| Time of maximum observed concentration [Tmax] | Up to 105 days | |
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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 | San Antonio | Texas | 78209 | 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/disclosurecommitment.html
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| Apparent terminal half-life [T-HALF] |
| Up to 105 days |
| Incidence of adverse events (AEs) | Up to approximately 5 months |
| Incidence of serious adverse events (SAEs) | Up to approximately 5 months |
| Incidence of participants with vital sign abnormalities | Up to 105 days |
| Incidence of participants with physical examinations abnormalities | Up to 105 days |
| Incidence of participants with electrocardiogram (ECG) abnormalities | Up to 105 days |
| Incidence of participants with clinical laboratory abnormalities | Up to 105 days |