A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants

CY 8011

1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects. 2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses. 3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.

2022-12-06

2023-12-01

2024-01-01

Recruiting

Early phase I

78

Inclusion Criteria: * Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg. Exclusion Criteria: Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated: * History of any significant illness or disorder. * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed). * History or presence of: 1. additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). 2. sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities. * Clinically significant illness within 4 weeks prior to check in. * Participants with an inability to swallow tablets.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}

2023-05-25