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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: CK-3828136; Drug: Placebo for CK-3828136

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Labcorp Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential 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-3828136; Placebo for CK-3828136
Placebo Comparator: Placebo for MAD Cohort; Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo	Drug: Placebo for CK-3828136; Placebo for CK-3828136
Experimental: Food Effect; Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.	Drug: CK-3828136; CK-3828136
Experimental: CK-3828136 for SAD Cohort; Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136	Drug: CK-3828136; CK-3828136
Experimental: CK-3828136 for MAD Cohort; Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136	Drug: CK-3828136; CK-3828136

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-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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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)

Collaborators and Investigators

• Sponsor: Cytokinetics
• Investigators: Study Director: Cytokinetics, MD, Cytokinetics

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: CK-3828136, CK-136
• Other Study ID Numbers: CY 8011

Drug and device information, study documents

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