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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05877053

Healthy Participants

COMPLETED PHASE1

A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects

NCT03767855

Symptomatic Obstructive Hypertrophic Cardiomyopathy Healthy Subjects

COMPLETED PHASE1

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

NCT04746287

Healthy Volunteers

COMPLETED PHASE1

A Study of AZD4205 in Healthy Adult Subjects

NCT03728023

Healthy Volunteers

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

NCT01051505

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CK-3828136 for SAD Cohort

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

Group Type EXPERIMENTAL

CK-3828136

Intervention Type DRUG

CK-3828136

Placebo for SAD Cohort

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

Group Type PLACEBO_COMPARATOR

Placebo for CK-3828136

Intervention Type DRUG

Placebo for CK-3828136

CK-3828136 for MAD Cohort

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

Group Type EXPERIMENTAL

CK-3828136

Intervention Type DRUG

CK-3828136

Placebo for MAD Cohort

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

Group Type PLACEBO_COMPARATOR

Placebo for CK-3828136

Intervention Type DRUG

Placebo for CK-3828136

Food Effect

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

Group Type EXPERIMENTAL

CK-3828136

Intervention Type DRUG

CK-3828136

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CK-3828136

Intervention Type DRUG

Placebo for CK-3828136

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes