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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
114
CK-3773274 formulated as granules in capsule
Placebo formulated as granules in capsule
CK-3773274 formulated as tablets
Clinical Site
Tempe, Arizona, United States
Incidence of Adverse events and Safety Signals observed during single and multiple ascending doses of CK-3773274 administered orally to healthy adult subjects.
Subject incidence of AEs, SAEs, and reduced LVEF
Time frame: 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
Cmax of CK-3773274 after single and multiple ascending doses
Maximum concentration after dosing (Cmax) following single and multiple doses of CK-3773274 administered to healthy subjects
Time frame: SAD Cohorts: Day 1; CYP2D6 Cohort: Day 1; MAD Cohorts: Day 14 or Day 17; Food Effect Cohort: Day 15; Relative Bioavailability Cohort: Day 15
Change in absolute reduction in ejection fraction relative to baseline with doses of CK-3773274
Changes from baseline in LVEF as measured by echocardiography with doses of CK-3773274
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 10; Time Frame for CYP2D6 Cohort: Day -1 - Day 24; Time Frame for MAD Cohorts: Day -1 - Day 27
Assess the effect of CYP2D6 genetic variants on the PK of CK-3773274
Maximum concentration after dosing (Cmax) following a single dose administered to CYP2D6 poor metabolizers
Time frame: Day -1 - Day 24
Assess the effect of a meal on how much CK-3773274 is in the blood in healthy subjects
Maximum concentration after dosing (Cmax) following single and multiple doses of CK-3773274 administered to healthy subjects in fed and fasted states
Time frame: Day -1 - Day 24
Relative bioavailability of CK-3773274 formulated as granules in capsule versus a tablet in healthy adult subjects
PK parameters such as AUC calculated using plasma concentrations of CK-3773274
Time frame: Time Frame for Bioavailability Cohort: Day -1 - Day 29
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