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

• Sponsor: Cytokinetics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05877053
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: CK-4021586; Drug: Placebo for CK-4021586	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
• Actual Study Start Date: May 9, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
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 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

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of AEs [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 Outcome Measures

1. 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)]

   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 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Tempe	Arizona	United States	85283

Sponsors and Collaborators

• Cytokinetics

Investigators

• Study Director: Scientific Leadership at Cytokinetics, Cytokinetics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cytokinetics
• ClinicalTrials.gov Identifier: NCT05877053
• Other Study ID Numbers: CY 9011
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cytokinetics: CK-586; CK-4021586

Study Results

No Results Posted as of May 26, 2023