A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: Placebo for CK-4021586
- Registration Number
- NCT05877053
- Lead Sponsor
- Cytokinetics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo for MAD Cohort Placebo for CK-4021586 Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo CK-4021586 for SAD Cohort CK-4021586 Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 Placebo for SAD Cohort Placebo for CK-4021586 Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo Food Effect CK-4021586 Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion CK-4021586 for MAD Cohort CK-4021586 Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586
- 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-4021586 when administered orally as single or multiple doses to healthy participants
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States