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:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01461967
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
* Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose
Exclusion Criteria:
* Suspicion of regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV infection
* History of hypersensitivity or severe drug reaction
* Participation in an investigational drug or device study within three months before the first drug administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01461967
Study Brief:
Protocol Section:
NCT01461967