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

NCT05662215 | Terminated Phase 1 FDA Drug

• 1 other identifier: CY 8011
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects.
2. 2.Find out how much CK-3828136 is in the blood after a single dose and multiple doses.
3. 3.Determine the effect different doses of CK-3828136 on the pumping function of the heart.

Conditions

Healthy Participants

Keywords

CK-3828136, CK-136

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Primary PK parameters of CK-3828136 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)

• 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

• PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state

  Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2)

Study Arms (5)

CK-3828136 for SAD Cohort

EXPERIMENTAL

Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136

Drug: CK-3828136

Placebo for SAD Cohort

PLACEBO COMPARATOR

Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo

Drug: Placebo for CK-3828136

CK-3828136 for MAD Cohort

EXPERIMENTAL

Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136

Drug: CK-3828136

Placebo for MAD Cohort

PLACEBO COMPARATOR

Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo

Drug: Placebo for CK-3828136

Food Effect

EXPERIMENTAL

Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.

Drug: CK-3828136

Interventions

CK-3828136 DRUG

CK-3828136

CK-3828136 for MAD Cohort; CK-3828136 for SAD Cohort; Food Effect

Placebo for CK-3828136 DRUG

Placebo for CK-3828136

Placebo for MAD Cohort; Placebo for SAD Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cytokinetics: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

Study Officials

• Cytokinetics, MD

  Cytokinetics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: December 6, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

US (1)