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 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00721812
Eligibility Criteria:
Inclusion criteria:
* Healthy as determined by a responsible physician
* Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.
* Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).
* QTcB or QTcF \< 450 msec
* Capable of giving written informed consent
Exclusion criteria:
* The subject has a positive pre-study drug/alcohol screen
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units
* Urinary cotinine levels indicative of active smoking or regular use of tobacco
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
* A positive test for HIV antibody
* The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product
* Exposure to more than four new chemical entities within 12 months
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days
* Subject is receiving hormone replacement therapy
* History of sensitivity to any of the study medications
* History of sensitivity to heparin or heparin-induced thrombocytopenia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00721812
Study Brief:
Protocol Section:
NCT00721812