Clinical trial NCT06476821: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/Exclusion criteria apply.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 30
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 30
measure: Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 30
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: From date of written consent up to 28 days post last dose
measure: Number of participants with Serious Adverse Events
timeFrame: From date of written consent up to 28 days post last dose
measure: Number of participants with AEs leading to discontinuation
timeFrame: From date of written consent up to 28 days post last dose
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 31
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 31
measure: Number of participants with echocardiogram abnormalities
timeFrame: Up to Day 30
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 31
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 31
measure: Echocardiographic measures of cardiac systolic function: left ventricular ejection fraction (LVEF)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac systolic function: left ventricular outflow tract velocity time integral (LVOT-VTI)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac systolic function: left ventricular fractional shortening (LVFS)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac systolic function: left ventricle stroke volume (LVSV)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e')
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac diastolic function: septal e'
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: LV mass index
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: LV atrial volume index
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: interventricular septal thickness
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: posterior wall thickness
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: LV end diastolic volume
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: LV end systolic volume
timeFrame: Up to Day 30
measure: Echocardiographic measures of cardiac structure: LV end systolic volume index
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Xuhui District
country: China
facility: Local Institution - 0001
state: Shanghai
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: