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The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: Period A | Experimental |
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| Part I: Period B | Experimental |
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| Part I: Period C | Experimental |
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| Part II: Period 1 | Experimental |
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| Part II: Period 2 | Experimental |
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| Part II: Period 3 | Experimental |
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| Part III: Period 1 | Experimental |
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| Part III: Period 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Specified Dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3) | |
| Area under the plasma concentration-time curve within a dosing interval AUC(TAU) | Day 4, 17 and 21 of Part 1 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) | Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) | Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with non-serious AEs (Adverse events) | Up to 28 Days post discontinuation of dosing | |
| Number of participants with Serious AEs | Up to 28 Days post discontinuation of dosing | |
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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 | Lenexa | Kansas | 66219 | 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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|
| BMS 986278 |
| Drug |
Specified dose on specified days |
|
| Number of participants with AEs leading to discontinuation |
| Up to 28 Days post discontinuation of dosing |
| Number of participants with Physical examination abnormalities | Up to 28 Days post discontinuation of dosing |
| Number of participants with vital sign abnormalities | Up to 28 Days post discontinuation of dosing |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to 28 Days post discontinuation of dosing |
| Number of participants with clinical laboratory abnormalities | Up to 28 Days post discontinuation of dosing |
| Time of maximum observed plasma concentration (Tmax) | Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2) |
| Apparent terminal phase half-life (T-HALF) | Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) |
| Apparent total body clearance (CLT/F) | Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) |
| Apparent volume of distribution of terminal phase (Vz/F) | Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) |
| ID | Term |
|---|---|
| C530716 | nintedanib |
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