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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01702194
Eligibility Criteria:
Inclusion Criteria:
1. Healthy, nonsmoking male, 18 to 50 years old, inclusive.
2. Agrees to use a highly effective method of birth control.
3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
4. Willing and able to give written informed consent.
Exclusion Criteria:
1. Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
2. Hemoglobin \<14.1 g/dL or hematocrit \< 40.6% at Screening.
3. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
4. Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]).
5. Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01702194
Study Brief:
Protocol Section:
NCT01702194