Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGBMS-986435
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening. * Participants must be Chinese (both biological parents are ethnically Chinese). * Participant has documented LVEF ≥ 60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.
Exclusion criteria
* Any acute or chronic medical illness. * Head injury in the last 2 years, intracranial tumor, or aneurysm. * History of malignancy of any type, except in situ cervical cancer \> 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers \> 2 years prior to the screening visit. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with clinical laboratory abnormalities | Up to Day 31 |
| 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 |
| 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 |
| 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 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 31 |
| 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 |
| Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e') | Up to Day 30 |
| Number of participants with echocardiogram abnormalities | Up to Day 30 |
| Number of participants with physical examination abnormalities | Up to Day 31 |
Countries
China
Outcome results
None listed