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This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BMS-986368 - Fasted | Experimental |
| |
| Part 1: Itraconazole - Fasted | Experimental |
| |
| Part 1: BMS-986368 with Itraconazole - Fasted | Experimental |
| |
| Part 2: BMS-986368 - Fasted | Experimental |
| |
| Part 2: BMS-986368 - Fed | Experimental |
| |
| Part 2: Famotidine, followed by BMS-986368 - Fasted | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986368 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 11 days | |
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) | Up to 11 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 41 days | |
| Number of participants with physical examination abnormalities | Up to 17 days | |
| Number of participants with vital sign abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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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 | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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 Myers 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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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Specified dose on specified days |
|
| Famotidine | Drug | Specified dose on specified days |
|
| Up to 17 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 17 days |
| Number of participants with clinical laboratory abnormalities | Up to 17 days |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 17 days |
| D010879 |
| Piperazines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |