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The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 BMS-986365 Dose 1 | Experimental |
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| Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 | Experimental |
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| Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 | Experimental |
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| Part 1: Cohort 3 BMS-986365 Dose 4 | Experimental |
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| Part 1: Cohort 6 BMS-986365 Dose 5 | Experimental |
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| Part 1: Cohort 7 BMS-986365 Dose 6 | Experimental |
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| Part 1: Cohort 8 BMS-986365 Dose 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986365 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 75 | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] | Up to Day 75 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation | Up to Day 75 | |
| Incidence of adverse events (AE) | Up to Day 75 | |
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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/disclosurecommitment.html
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Part 1: Cohort 9 BMS-986365 Dose 8 |
| Experimental |
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| Part 2: Cohort 4 BMS-986365 Dose 9 Fasted | Experimental |
|
| Part 2: Cohort 4 BMS-986365 Dose 10 Fed | Experimental |
|
| Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 | Experimental |
|
|
| Rabeprazole | Drug | Specified dose on specified days |
|
| Incidence of serious adverse events (SAE) |
| Up to Day 75 |
| Number of participants with physical examination abnormalities | Up to Day 75 |
| Number of participants with vital sign abnormalities | Up to Day 75 |
| Number of participants with clinical laboratory abnormalities | Up to Day 75 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 75 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |