The purposes of this study are to: * Learn about the safety and tolerability of CK 4021586 after a single dose and multiple doses in healthy subjects. * Find out how much CK-4021586 is in the blood after a single dose and multiple doses. * Determine the effect different doses of CK-4021586 on the pumping function of the heart. * Determine the effect of food in the stomach on how much CK-4021586 is in the blood after a single dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
102
CK-4021586
Placebo for CK-4021586
Celerion
Tempe, Arizona, United States
Incidence and severity of AEs
To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2)
Primary PK parameters of CK-4021586 including AUC
To characterize the PK of CK-4021586 and CK-4022235 after single and multiple oral doses in healthy participants
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2)
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
To characterize the PD effects of single and multiple oral doses of CK-4021586 in healthy participants
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
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