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Completed

NCT Number: NCT05877053

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CK-4021586

Drug

CK-4021586

Placebo for CK-4021586

Drug

Placebo for CK-4021586

Primary outcomes

  1. Incidence and severity of AEs

    Time frame: 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 outcomes

  1. Primary PK parameters of CK-4021586 including AUC

    Time frame: 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

  2. Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cytokinetics

Industry

Registry information

Official study title

A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 26, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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