A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT05877053

Run by

Cytokinetics

People needed

102

Starts

2023-05-09

Expected to finish

2024-11-20

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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