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This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
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| Treatment B | Experimental |
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| Treatment C | Experimental |
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| Treatment D | Experimental |
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| Treatment E | Experimental |
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| Treatment F | Experimental |
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| Treatment G | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986435 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 28 | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 28 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h)) | Up to Day 28 | |
| Time of maximum observed concentration (Tmax) | Up to Day 28 | |
| Half-life (T-HALF) |
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Inclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Miami | Recruiting | Miami | Florida | 33126 | 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.html
See Plan Description
See Plan Description
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|
| Up to Day 28 |
| Apparent total body clearance (CLT/F) | Up to Day 28 |
| Volume of distribution of terminal phase (Vz/F) | Up to Day 28 |
| Number of participants with Adverse Events (AEs) | Up to Day 35 |
| Number of participants with Serious AEs (SAEs) | Up to Day 35 |
| Number of participants with clinical laboratory abnormalities | Up to Day 28 |
| Number of participants with vital sign abnormalities | Up to Day 28 |
| Number of participants with physical examination abnormalities | Up to Day 28 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 28 |