Status:
COMPLETED
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
Lead Sponsor:
Cytokinetics
Conditions:
Symptomatic Obstructive Hypertrophic Cardiomyopathy
Healthy Subjects
Eligibility:
All Genders
18-55 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 healthy subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single...
Eligibility Criteria
Inclusion
- Males and females (of non-childbearing potential) between 18 and 55 years of age, inclusive
- Body weight \> 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive
- Normal cardiac structure and function, or if abnormalities are present, they are deemed not clinically significant
- Normal to high left ventricular ejection fraction.
- Normal electrocardiogram (ECG) or, if abnormalities are present, they are deemed not clinically significant
- Clinical laboratory findings within normal range
- Negative hepatitis panel (including hepatitis B surface antigen and hepatitis C antibody), and negative human immunodeficiency virus antibody screens
- Willing and able to refrain from strenuous exercise (eg, activity which could be expected to cause muscle soreness)
- For Arms 5 and 6 only: Subject is a CYP2D6 poor metabolizer
Exclusion
- History of any significant illness or disorder
- History of stomach or intestinal surgery or resection (appendectomy, hernia repair, and/or cholecystectomy will be allowed)
- A clinically significant illness within 4 weeks of Check-in
- Inability to swallow capsules or tablets
- History of or current substance abuse (drug or alcohol), known drug or alcohol dependence within the last 2 years prior to Screening, or positive test for drugs of abuse during the screening period
- Use of any tobacco-containing or nicotine-containing products within 3 months prior to Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in
- Any blood donation within 60 days of dosing, plasma donation within 30 days of dosing, or receipt of blood products within 2 months prior to Check-in
Key Trial Info
Start Date :
December 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03767855
Start Date
December 4 2018
End Date
January 3 2020
Last Update
January 24 2025
Active Locations (1)
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1
Clinical Site
Tempe, Arizona, United States, 85283