Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
Lead Sponsor:
Corxel Pharmaceuticals
Collaborating Sponsors:
Cytokinetics
Conditions:
Obstructive Hypertrophic Cardiomyopathy
Healthy Adult Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Healthy Chinese males and females between 18 and 45 years of age, inclusive
- Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
- Acoustic windows adequate for accurate transthoracic echocardiograms
- 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
- LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
- Normal ECG
Exclusion
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Subjects with breast implants that may impede echocardiography
- A clinically significant illness within 4 weeks prior to admission to the CRU
- Inability to swallow tablets
- Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
- Poor peripheral venous access
- 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
Key Trial Info
Start Date :
April 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04783766
Start Date
April 10 2021
End Date
August 5 2021
Last Update
January 24 2025
Active Locations (1)
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1
Clinical Site
Beijing, Beijing Municipality, China, 100032