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This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference tablet followed by BMS-986205 tablet with free base | Experimental | BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2). |
|
| BMS-986205 tablet with free base followed by reference tablet | Experimental | BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 reference tablet | Drug | Single, 100 mg oral dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet. | Measured by plasma concentration. | Up to Day 22 |
| Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet. | Measured by plasma concentration. | Up to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-serious Adverse Events (AEs). | Safety and tolerability as measured by incidence of non-serious AEs. | Up to Day 22 |
| Incidence of Serious Adverse Events (SAEs). | Safety and tolerability as measured by incidence of SAEs. |
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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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| BMS-986205 tablet with free base | Drug | Single, 100 mg oral dose. |
|
| Up to Day 22 |
| Incidence of Adverse Events (AEs) leading to discontinuation. | Safety and tolerability as measured by incidence of AEs leading to discontinuation. | Up to Day 22 |
| Number of participants with vital sign abnormalities. | Up to Day 22 |
| Number of participants with electrocardiogram (ECG) abnormalities. | Up to Day 22 |
| Number of participants with clinical laboratory abnormalities. | Up to Day 22 |
| Number of participants with physical examination abnormalities. | Up to Day 22 |
| ID | Term |
|---|---|
| C000630574 | linrodostat |
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