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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT00436228
Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
* Healthy adults between 18 and 60 years of age, inclusive.
* Body weight proportional to height.
* Capable of giving written informed consent.
* Female subjects must be of non-childbearing potential.
* QTc less than 450 msec at screening
Exclusion Criteria:
* Any clinically relevant abnormality identified on the screening history and physical or on the 12-lead surface electrocardiogram at screening or pre-dose.
* The subject has a positive pre-study alcohol/urine drug screen.
* History of regular use of tobacco, or nicotine-containing products.
* A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening.
* Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
* An unwillingness to comply with lifestyle and/or dietary restrictions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00436228
Study Brief:
Protocol Section:
NCT00436228