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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01367756
Eligibility Criteria:
Inclusion Criteria:
* Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
* Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
* Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
* Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug
Exclusion Criteria:
* Pregnant or lactating females
* Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
* Hepatitis B, hepatitis C or HIV infection
* Smokers of \>5 cigarettes or equivalent tobacco intake per day
* Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
* Participation in an investigational drug or device study within 3 months prior to dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01367756
Study Brief:
Protocol Section:
NCT01367756