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This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Sequence 1 | Experimental |
| |
| Part 1, Sequence 2 | Experimental |
| |
| Part 2, Sequence 1 | Experimental |
| |
| Part 2, Sequence 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 Batched method, Dose A | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 24 | |
| Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T)) | Up to Day 24 | |
| Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF)) | Up to Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Observed Plasma Concentration (Tmax) | Up to Day 24 | |
| Terminal Phase Half-life (T-HALF) | Up to Day 24 | |
| Apparent Total Body Clearance (CLT/F) |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials (ACT) | Anaheim | California | 92801 | 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
See plan description
See plan description
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| BMS-986278 Batched method, Dose B | Drug | Specified dose on specified days |
|
| BMS-986278 Continuous method | Drug | Specified dose on specified days |
|
| Up to Day 24 |
| Apparent Volume of Distribution (Vz/F) | Up to Day 24 |
| Number of Participants With Adverse Events (AEs) | Up to 28 Days Post-discontinuation of Study Intervention |
| Number of Participants With Clinical Laboratory Abnormalities | Up to Day 25 |
| Number of Participants With Vital Sign Abnormalities | Up to Day 25 |
| Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities | Up to Day 25 |