1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects. 2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses. 3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
57
CK-3828136
Placebo for CK-3828136
Labcorp Clinical Research Unit Inc.
Dallas, Texas, United States
Incidence and severity of AEs
To assess the safety and tolerability of CK-3828136 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-3828136 including AUC
To characterize the PK of CK-3828136 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-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Time frame: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
PK parameters following single multiple doses in fed and fasted state
Time frame: Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)
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