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The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986435 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 30 | |
| Time of maximum observed concentration (Tmax) | Up to Day 30 | |
| Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | From date of written consent up to 28 days post last dose | |
| Number of participants with Serious Adverse Events | From date of written consent up to 28 days post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Xuhui District | Shanghai Municipality | 200032 | China |
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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/disclosure-commitment.html
See plan description
See plan description
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| Number of participants with AEs leading to discontinuation | From date of written consent up to 28 days post last dose |
| Number of participants with vital sign abnormalities | Up to Day 31 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 31 |
| Number of participants with echocardiogram abnormalities | Up to Day 30 |
| Number of participants with physical examination abnormalities | Up to Day 31 |
| Number of participants with clinical laboratory abnormalities | Up to Day 31 |
| Echocardiographic measures of cardiac systolic function: left ventricular ejection fraction (LVEF) | Up to Day 30 |
| Echocardiographic measures of cardiac systolic function: left ventricular outflow tract velocity time integral (LVOT-VTI) | Up to Day 30 |
| Echocardiographic measures of cardiac systolic function: left ventricular fractional shortening (LVFS) | Up to Day 30 |
| Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS) | Up to Day 30 |
| Echocardiographic measures of cardiac systolic function: left ventricle stroke volume (LVSV) | Up to Day 30 |
| Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e') | Up to Day 30 |
| Echocardiographic measures of cardiac diastolic function: septal e' | Up to Day 30 |
| Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e') | Up to Day 30 |
| Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio) | Up to Day 30 |
| Echocardiographic measures of cardiac structure: LV mass index | Up to Day 30 |
| Echocardiographic measures of cardiac structure: LV atrial volume index | Up to Day 30 |
| Echocardiographic measures of cardiac structure: interventricular septal thickness | Up to Day 30 |
| Echocardiographic measures of cardiac structure: posterior wall thickness | Up to Day 30 |
| Echocardiographic measures of cardiac structure: LV end diastolic volume | Up to Day 30 |
| Echocardiographic measures of cardiac structure: LV end systolic volume | Up to Day 30 |
| Echocardiographic measures of cardiac structure: LV end systolic volume index | Up to Day 30 |