A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects (NCT03767855) | Clinical Trial Compass
CompletedPhase 1
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
United States114 participantsStarted 2018-12-04
Plain-language 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 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 of cytochrome genetic variants on how the body metabolizes CK-3773274.
6. Evaluate the effect of a meal on how much CK-3773274 is in the blood in healthy adult subjects.
7. Evaluate whether the amount of CK-3773274 in the blood is the similar for both the tablet and granules in capsule forms of the drug.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. History of any significant illness or disorder
What they're measuring
1
Incidence of Adverse events and Safety Signals observed during single and multiple ascending doses of CK-3773274 administered orally to healthy adult subjects.
Timeframe: SAD Cohorts: Day -1 - Day 10; CYP2D6 Cohort: Day -1 - Day - 24; MAD Cohorts: Day -1 - Day 27; Food Effect Cohort: Day -1 - Day 24; relative Bioavailability Cohort: Day -1 - Day 29
✕. 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