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The purpose of this study is to investigate the effect of a light meal and a high-fat meal on the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants. Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986205 under fasted conditions then with high-fat meal. | Experimental | Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a high-fat meal (Day 15). |
|
| BMS-986205 with high-fat meal then under fasted conditions. | Experimental | Single, 100 mg dose of BMS-986205 with a high-fat meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15). |
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| BMS-986205 under fasted conditions then with light meal. | Experimental | Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a light meal (Day 15). |
|
| BMS-986205 with light meal then under fasted conditions. | Experimental | Single, 100 mg dose of BMS-986205 with a light meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Single dose, 100 mg administered at Day 1 and at Day 15. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal. | Measured by plasma concentration. | Up to 21 days |
| Area under the plasma concentration-time curve from time zero to 168 hours (AUC[0-168]) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal. | Measured by plasma concentration. | Up to 21 days |
| Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal. | Measured by plasma concentration. | Up to 21 days |
| AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal. | Measured by plasma concentration. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) following administration of single, 100 mg tablet of BMS-986205 under fasting conditions, with a light meal or with a high-fat meal. | Safety and tolerability of BMS-986205 measured by investigator assessment. | Day 1 up to Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Austin Clinic | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
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| Results of clinical laboratory tests |
Measured by Investigator assessment |
| Up to 22 days |
| Results of vital sign measurements | Measured by Investigator assessment | Up to 22 days |
| Results of electrocardiogram (ECG) | Measured by Investigator Assessment | Up to 22 days |