A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT05662215

Run by

Cytokinetics

People needed

57

Starts

2022-12-06

Expected to finish

2023-08-08

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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).
• 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.
• Clinically significant illness within 4 weeks prior to check in.
• Participants with an inability to swallow tablets.

Where it is running

• Labcorp Clinical Research Unit Inc. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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