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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00452504
Eligibility Criteria:
Inclusion criteria:
* Healthy men or women of nonchildbearing potential aged 18 to 50 years,
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
Exclusion criteria:
* Family history of sudden death and/or QT prolongation.
* An automatic ECG corrected QT (QTc) interval reading at screening \>450 ms and \>470 ms for male and female subjects, respectively.
* Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening \<110 mm Hg (systolic) and/or \<60 mm Hg (diastolic).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00452504
Study Brief:
Protocol Section:
NCT00452504