A Single and Multiple Ascending Dose Study of CK-4021586 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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2024-11-20

Brief Summary

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

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.

Related Clinical Trials

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

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

NCT05662215

Healthy Participants

TERMINATED PHASE1

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

NCT03767855

Symptomatic Obstructive Hypertrophic Cardiomyopathy Healthy Subjects

COMPLETED PHASE1

Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

NCT03979859

Healthy

COMPLETED PHASE1

A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy Participants

NCT05156034

Healthy Participants

TERMINATED PHASE1

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

NCT04746287

Healthy Volunteers

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

PARALLEL

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-4021586 for SAD Cohort

Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586

Group Type EXPERIMENTAL

CK-4021586

Intervention Type DRUG

CK-4021586

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-4021586

Intervention Type DRUG

Placebo for CK-4021586

CK-4021586 for MAD Cohort

Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586

Group Type EXPERIMENTAL

CK-4021586

Intervention Type DRUG

CK-4021586

Placebo for MAD Cohort

Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo

Group Type PLACEBO_COMPARATOR

Placebo for CK-4021586

Intervention Type DRUG

Placebo for CK-4021586

Food Effect

Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion

Group Type EXPERIMENTAL

CK-4021586

Intervention Type DRUG

CK-4021586

Interventions

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

CK-4021586

Intervention Type DRUG

Placebo for CK-4021586

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes