Healthy Participants
Conditions
Keywords
CK-586, CK-4021586
Brief summary
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.
Interventions
DRUGCK-4021586
CK-4021586
DRUGPlacebo for CK-4021586
Placebo for CK-4021586
Sponsors
Cytokinetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg
Exclusion criteria
* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic, dermatologic, hepatic, renal, hematologic, respiratory, cardiovascular (including arrhythmia), gastrointestinal, gallbladder/biliary, musculoskeletal, neurologic, or psychiatric disorder in the opinion of the Investigator or designee. * History of significant hypersensitivity or allergy to any drug compound or other substance, unless approved by the Investigator and the Sponsor's Medical Monitor. * 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). * Participants with breast implants that may impede echocardiography * Clinically significant illness within 4 weeks prior to check in. * Significant ECG abnormalities (heart block, prolonged QT interval, arrhythmia) * 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 * Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study, in the judgment of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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-4021586 when administered orally as single or multiple doses to healthy participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary PK parameters of CK-4021586 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-4021586 and CK-4022235 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-4021586 in healthy participants |
Countries
United States
Outcome results
None listed