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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01409369
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects, 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
* Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.
Exclusion Criteria:
* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
* Any confirmed allergic reaction against any drug or multiple allergies
* Dietary restrictions that would prohibit the consumption of standardized meals
* Positive cotinine test and/or any use of nicotine containing products
* Clinically relevant history of constipation or bowel disorder
* Known intolerability to activated charcoal
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01409369
Study Brief:
Protocol Section:
NCT01409369