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:
NCT01038167
Eligibility Criteria:
Inclusion Criteria:
* Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)
* Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.
Exclusion Criteria:
* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.
* Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01038167
Study Brief:
Protocol Section:
NCT01038167