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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01495104
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers, 18 to 65 years of age inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
* Non smoker or smoker of fewer than 10 cigarettes per day
Exclusion Criteria:
* History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
* Alcohol consumption averaging more than 24 g of alcohol per day
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
* Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
* Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01495104
Study Brief:
Protocol Section:
NCT01495104