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

Cytokinetics

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo for CK-3828136; Drug: CK-3828136

Study type: Interventional

Funder types: Industry

Identifiers

NCT05662215

CY 8011

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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:

  1. additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
  2. 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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57 participants in 5 patient groups, including a placebo group

CK-3828136 for SAD Cohort

Experimental group

Description:

Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136

Treatment:

Drug: CK-3828136

Placebo for SAD Cohort

Placebo Comparator group

Description:

Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo

Treatment:

Drug: Placebo for CK-3828136

CK-3828136 for MAD Cohort

Experimental group

Description:

Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136

Treatment:

Drug: CK-3828136

Placebo for MAD Cohort

Placebo Comparator group

Description:

Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo

Treatment:

Drug: Placebo for CK-3828136

Food Effect

Experimental group

Description:

Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.

Treatment:

Drug: CK-3828136