Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT03496168
Eligibility Criteria:
Key Inclusion Criteria:
* Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
* Body weight \> 45 kg at Screening
* Has safety laboratory parameters (chemistry and hematology) within normal limits
Key Exclusion Criteria:
* Has QTcF \> \> 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
* Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (\> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
* Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
* Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03496168
Study Brief:
Protocol Section:
NCT03496168