A Study to Evaluate the Effects of Mavacamten in Healthy 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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-07-25

Brief Summary

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

The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.

Related Clinical Trials

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

A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

NCT05362045

Healthy Participants

COMPLETED PHASE1

A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

NCT05658146

Healthy Participants

COMPLETED PHASE1

A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers

NCT03860948

Bioequivalence

COMPLETED PHASE1

Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

NCT00864604

Healthy

COMPLETED PHASE1

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

NCT00864968

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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Mavacamten Dose 1

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Mavacamten Dose 2

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Interventions

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

Mavacamten

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MYK-461

Eligibility Criteria

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

Inclusion Criteria

* Body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit.
* Healthy, as determined by physical examination, vital signs, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded.
* Cytochrome P450 (CYP2C19) normal (\*1/\*1), rapid (\*1/\*17), or ultra-rapid (\*17/\*17) metabolizer, as determined by genotyping during screening.

Exclusion Criteria

* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
* Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes