A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants

Healthy Participants Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662215
• Other study ID #: CY 8011
• Status: Recruiting
• Phase: Phase 1
• Start date: December 6, 2022
• Est. completion date: January 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

1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects.

2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses.

3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male and female participants aged between 18 and 45 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:

Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:

• History of any significant illness or disorder.

• 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).

• History or presence of:

1. additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).

2. sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.

• Clinically significant illness within 4 weeks prior to check in.

• Participants with an inability to swallow tablets.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• CK-3828136
CK-3828136
• Placebo for CK-3828136
Placebo for CK-3828136

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit Inc.	Dallas	Texas

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-3828136 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-3828136 including AUC	To characterize the PK of CK-3828136 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-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14	Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14
Secondary	PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state	PK parameters following single multiple doses in fed and fasted state	Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)