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The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Dose 1 | Experimental |
| |
| Panel 2: Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986166 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax) | Day 1, Day 28 | |
| PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax) | Day 1, Day 28 | |
| PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU)) | Day 1, Day 28 | |
| PK parameters of BMT-121795: Cmax | Day 1, Day 28 | |
| PK parameters of BMT-121795: Tmax | Day 1, Day 28 | |
| PK parameters of BMT-121795: AUC(TAU) | Day 1, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events (AEs) | Up to 77 days | |
| Severity of all AEs | Up to 77 days | |
| Outcome of all AEs |
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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 |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials Global | Cypress | California | 90630 | 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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| ID | Term |
|---|---|
| C000706608 | BMS-986166 |
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| Placebo |
| Other |
Specified dose on specified days |
|
| Up to 77 days |
| Incidence of all serious adverse events (SAEs) | Up to 77 days |
| Severity of all SAEs | Up to 77 days |
| Outcome of all SAEs | Up to 77 days |
| Severity of all AEs regardless of seriousness criteria | Up to 77 days |
| Investigator causality assessment of all AEs regardless of seriousness criteria | Up to 77 days |
| Outcomes of all AEs regardless of seriousness criteria | Up to 77 days |
| Incidence of clinically significant changes in physical examination findings | Up to 77 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 77 days |
| Incidence of clinically significant changes in ECG parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization | Up to 77 days |
| Incidence of clinically significant changes in ECG parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 77 days |
| Incidence of clinically significant changes in ECG parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 77 days |
| Incidence of clinically significant changes in continuous cardiac monitoring data | Up to 77 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 77 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 77 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 77 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 77 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 77 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 77 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 77 days |
| Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval | Up to 77 days |
| Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval | Up to 77 days |
| Incidence of clinically significant changes from baseline values in ECG parameters: QT interval | Up to 77 days |
| Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval | Up to 77 days |
| Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data | Up to 77 days |
| Incidence of clinically significant changes from baseline values in vital signs: Body temperature | Up to 77 days |
| Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate | Up to 77 days |
| Incidence of clinically significant changes from baseline values in vital signs: Blood pressure | Up to 77 days |
| Incidence of clinically significant changes from baseline values in vital signs: Heart rate | Up to 77 days |
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests | Up to 77 days |
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests | Up to 77 days |
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests | Up to 77 days |
| FDA Safety Alerts and Recalls | View source |