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The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD | Experimental | SAD = Single Ascending Dose |
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| Part B: MAD | Experimental | MAD = Multiple Ascending Dose |
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| Part C: JMAD | Experimental | JMAD= Japanese Multiple Ascending Dose |
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| Part D: FE/BA | Experimental | FE/BA = Food Effect/Relative Bioavailability |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986172 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-serious Adverse Events (AEs) | Up to 35 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 35 days | |
| Incidence of AEs leading to discontinuation of study treatment | Up to 35 days | |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 28 days | |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 28 days | |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 28 days | |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 28 days | |
| Incidence of clinically significant changes in physical examination | Up to 28 days | |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 28 days | |
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests | Up to 28 days | |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of BMS-986172 | Up to 28 days | |
| Maximum observed plasma concentration (Cmax) | Up to 28 days | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |
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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 |
|---|---|---|---|---|---|---|
| ICON Plc (Legacy PRA) | Lenexa | Kansas | 66215 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Placebo | Other | Specified dose on specified days |
|
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests |
| Up to 28 days |
| Incidence of clinically significant changes in clinical laboratory values: Serology tests | Up to 28 days |
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 28 days |
| Up to 28 days |
| FDA Safety Alerts and Recalls | View source |