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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01607034
Eligibility Criteria:
Inclusion Criteria:
* Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
* Adult males/females aged 18 to 55 years inclusive.
* Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.
Exclusion Criteria:
* History of malignant disease, including solid tumors and hematologic malignancies.
* History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
* Surgery within 90 days prior to check in.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01607034
Study Brief:
Protocol Section:
NCT01607034