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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877053
• Other study ID #: CY 9011
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: Cytokinetics
• Contact: Cytokinetics MD
• Phone: 650-624-2929
• Email: medicalaffairs[@]cytokinetics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• CK-4021586
CK-4021586
• Placebo for CK-4021586
Placebo for CK-4021586

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cytokinetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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