A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
NCT ID: NCT05658146
Last Updated: 2023-10-11
Study Results
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.
COMPLETED
PHASE1
95 participants
INTERVENTIONAL
2023-01-06
2023-07-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
NCT05719805
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
NCT02476864
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
NCT00864968
A Study to Evaluate the the Bioequivalence of Two Different Pimicotinib Capsules in Healthy Subjects
NCT07126249
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequence 1
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Sequence 2
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Sequence 3
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Sequence 4
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Sequence 5
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Sequence 6
Mavacamten Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
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 Capsule 1
Specified dose on specified days
Mavacamten Capsule 2
Specified dose on specified days
Mavacamten Capsule 3
Specified dose on specified days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
* Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.
Exclusion Criteria
* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
* CYP2C19 poor (\*2/\*2, \*3/\*3, or \*2/\*3) or intermediate (\*1/\*2, \*1/\*3, \*2/\*17) metabolizer, as determined by genotyping during screening.
* Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0001
Anaheim, California, United States
Local Institution - 0002
Miami, Florida, United States
Local Institution - 0003
Springfield, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CV027-1052
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.