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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01755494
Eligibility Criteria:
Inclusion Criteria:
* Chinese ethnicity which is defined as having both parents and 4 grandparents who are Chinese
* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Men, ages 18 to 40 years, inclusive. The age difference among the subjects is within 10 years
* Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
* Sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential
Exclusion Criteria:
* Any significant acute or chronic medical illness
* Current or recent gastrointestinal disease
* Subjects that have lymphocytopenia or thrombocytopenia
* History of autoimmune skin disorder
* Estimatedcreatinine clearance of less than 80 mL/min
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01755494
Study Brief:
Protocol Section:
NCT01755494