A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants
- Conditions
- Healthy Participants
- Interventions
- Drug: Placebo for CK-3828136
- Registration Number
- NCT05662215
- Lead Sponsor
- Cytokinetics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
- Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight > 50.0 kg.
Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:
-
History of any significant illness or disorder.
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History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
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History or presence of:
- additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.
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Clinically significant illness within 4 weeks prior to check in.
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Participants with an inability to swallow tablets.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo for SAD Cohort Placebo for CK-3828136 Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo Food Effect CK-3828136 Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion. Placebo for MAD Cohort Placebo for CK-3828136 Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo CK-3828136 for MAD Cohort CK-3828136 Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136 CK-3828136 for SAD Cohort CK-3828136 Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136
- Primary Outcome Measures
Name Time Method Incidence and severity of AEs 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) To assess the safety and tolerability of CK-3828136 when administered orally as single or multiple doses to healthy participants
- Secondary Outcome Measures
Name Time Method Primary PK parameters of CK-3828136 including AUC 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) To characterize the PK of CK-3828136 after single and multiple oral doses in healthy participants
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 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
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2) PK parameters following single multiple doses in fed and fasted state
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc.
🇺🇸Dallas, Texas, United States