Healthy Adult Subjects, Obstructive Hypertrophic Cardiomyopathy
Conditions
Keywords
CK-274, Obstructive hypertrophic cardiomyopathy, CK-3773274, oHCM, aficamten
Brief summary
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses. 4. Determine the effect of doses of CK-3773274 on the pumping function of the heart. 5. Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
Interventions
DRUGCK-3773274
CK-3773274- Tablets
DRUGPlacebo
Placebo- Tablets
Sponsors
Cytokinetics
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Chinese males and females between 18 and 45 years of age, inclusive 2. Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive 3. Acoustic windows adequate for accurate transthoracic echocardiograms 4. Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist 5. LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1 6. Normal ECG
Exclusion criteria
1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs 2. Subjects with breast implants that may impede echocardiography 3. A clinically significant illness within 4 weeks prior to admission to the CRU 4. Inability to swallow tablets 5. Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU 6. Poor peripheral venous access 7. Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE) | SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23 |
| Reduced Left Ventricular Ejection Fraction (LVEF) | SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of CK-3773274 after single and multiple ascending doses | SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23 |
Countries
China
Outcome results
None listed