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

A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, 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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: CK-4021586; Drug: Placebo for CK-4021586

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cytokinetics MD; Phone Number: 650-624-2929; Email: medicalaffairs@cytokinetics.com

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Recruiting
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo for SAD Cohort; Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo	Drug: Placebo for CK-4021586; Placebo for CK-4021586
Experimental: CK-4021586 for SAD Cohort; Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586	Drug: CK-4021586; CK-4021586
Experimental: CK-4021586 for MAD Cohort; Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586	Drug: CK-4021586; CK-4021586
Placebo Comparator: Placebo for MAD Cohort; Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo	Drug: Placebo for CK-4021586; Placebo for CK-4021586
Experimental: Food Effect; Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion	Drug: CK-4021586; CK-4021586

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary PK parameters of CK-4021586 including AUC	To characterize the PK of CK-4021586 and CK-4022235 after single and multiple oral doses in 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)
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF	To characterize the PD effects of single and multiple oral doses of CK-4021586 in healthy participants	Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14

Collaborators and Investigators

• Sponsor: Cytokinetics
• Investigators: Study Director: Scientific Leadership at Cytokinetics, Cytokinetics

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: CK-586; CK-4021586
• Other Study ID Numbers: CY 9011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No