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

Cytokinetics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: CK-4021586; Drug: Placebo for CK-4021586

Study type: Interventional

Funder types: Industry

Identifiers

NCT05877053

CY 9011

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 5 patient groups, including a placebo group

CK-4021586 for SAD Cohort

Experimental group

Description:

Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586

Treatment:

Drug: CK-4021586

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-4021586

CK-4021586 for MAD Cohort

Experimental group

Description:

Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586

Treatment:

Drug: CK-4021586

Placebo for MAD Cohort

Placebo Comparator group

Description:

Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo

Treatment:

Drug: Placebo for CK-4021586

Food Effect

Experimental group

Description:

Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion

Treatment:

Drug: CK-4021586