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The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986368 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to approximately Day 17 | |
| Time of maximum observed concentration (Tmax) | Up to approximately Day 17 | |
| Area under the concentration-time curve (AUC) | Up to approximately Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately Day 44 | |
| Number of participants with serious adverse events (SAEs) | Up to approximately Day 44 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| BMS-986368-matching Placebo |
| Other |
Specified dose of specified days |
|
| Number of participants with clinically significant vital sign measurements |
| Up to approximately Day 17 |
| Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations | Up to approximately Day 17 |
| Number of participants with clinically significant laboratory assessments | Up to approximately Day 17 |
| Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | Up to approximately Day 17 |
| Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI) | Up to approximately Day 17 |