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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01145768
Eligibility Criteria:
Inclusion Criteria:
* Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture
* Contraceptive use from the first dose of investigational product until12 weeks after their last dose
* Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
Exclusion Criteria:
* History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results of
* History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss
* Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01145768
Study Brief:
Protocol Section:
NCT01145768