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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT01775761
Eligibility Criteria:
Inclusion Criteria:
* Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* An ALT or AST measurement \>2 times the ULN.
* 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening.
* Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
* History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01775761
Study Brief:
Protocol Section:
NCT01775761