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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT01787357
Eligibility Criteria:
Inclusion Criteria:
* Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
* Volunteers must have an average of triplicate 12-lead electrocardiogram (ECG) recordings, taken with a maximum of 2 minutes between recordings, consistent with normal cardiac conduction and function, as specified by the protocol
* Volunteers must be non-smokers
Exclusion Criteria:
* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01787357
Study Brief:
Protocol Section:
NCT01787357