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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01396135
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
* Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Females of childbearing potential.
* Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations \>100 ng/mL at any time during the study will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01396135
Study Brief:
Protocol Section:
NCT01396135