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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004518-32 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Single Ascending Dose (SAD) Cohort A1 | Experimental |
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| Part A SAD Cohort A2 | Experimental |
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| Part A SAD Cohort A3 | Experimental |
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| Part A SAD Cohort A4 | Experimental |
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| Part A SAD Cohort A5 | Experimental |
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| Part A SAD Cohort A6 | Experimental |
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| Part B Multiple Ascending Dose (MAD) Cohort B1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986337 | Drug | Specified Dose on Specified Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 30 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 81 days | |
| Incidence of AEs leading to discontinuation | Up to 30 days | |
| Number of clinically significant changes in clinical laboratory values: Hematology tests | Up to 51 days | |
| Number of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 51 days | |
| Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 51 days | |
| Number of clinically significant changes from baseline in vital signs: Heart Rate | Up to 51 days | |
| Number of clinically significant changes from baseline in vital signs: Body Temperature | Up to 51 days | |
| Number of clinically significant changes from baseline in vital signs: Blood Pressure | Up to 51 days | |
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate | Up to 51 days |
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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 (PRA Health Sciences) - Netherlands | Groningen | 9728 NZ | Netherlands |
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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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| ID | Term |
|---|---|
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Part B MAD Cohort B2 | Experimental |
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| Part B MAD Cohort B3 | Experimental |
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| Part B MAD Cohort B4 | Experimental |
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| Part C MAD in Japanese Healthy participants Cohort C1 | Experimental |
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| Part C MAD in Japanese Healthy participants Cohort C2 | Experimental |
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| Part C MAD in Japanese Healthy participants Cohort C3 | Experimental |
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| BMS-986337 Placebo | Other | Specified Dose on Specified Days |
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| Famotidine | Biological | Specified Dose on Specified Days |
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| Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR) | Up to 51 days |
| Number of clinically significant changes from baseline in physical examinations | Up to 51 days |
| Number of clinically significant changes in ECG parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 51 days |
| Number of clinically significant changes in ECG parameters: QRS duration | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 51 days |
| Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's) | 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 51 days |
| Number of clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave. | Up to 51 days |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |