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

NCT05877053 | Completed Phase 1 FDA Drug

• 1 other identifier: CY 9011
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

CK-586; CK-4021586

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of AEs

  To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants

  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)

Secondary Outcomes (2)

• Primary PK parameters of CK-4021586 including AUC

  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)

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

  Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14

Study Arms (5)

CK-4021586 for SAD Cohort

EXPERIMENTAL

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

Drug: CK-4021586

Placebo for SAD Cohort

PLACEBO COMPARATOR

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

Drug: Placebo for CK-4021586

CK-4021586 for MAD Cohort

EXPERIMENTAL

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

Drug: CK-4021586

Placebo for MAD Cohort

PLACEBO COMPARATOR

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

Drug: Placebo for CK-4021586

Food Effect

EXPERIMENTAL

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

Drug: CK-4021586

Interventions

CK-4021586 DRUG

CK-4021586

CK-4021586 for MAD Cohort; CK-4021586 for SAD Cohort; Food Effect

Placebo for CK-4021586 DRUG

Placebo for CK-4021586

Placebo for MAD Cohort; Placebo for SAD Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Cytokinetics: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Scientific Leadership at Cytokinetics

  Cytokinetics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: May 9, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)