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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00743405
Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
* Male or female between 18 and 55 years of age.
* A female subject is eligible to participate if she is of non-childbearing potential
* Body weight \> 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
* Demonstrates no evidence of mental impairment.
* No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview
Exclusion Criteria:
* A positive pre-study drug/alcohol screen.
* A positive pre-study Hepatitis B , Hepatitis C or HIV.
* History of regular alcohol consumption.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Pregnant females, females planning pregnancy or lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Subjects with a current or a history of psychiatric illness.
* Subjects with any history of suicidal attempts or behavior.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00743405
Study Brief:
Protocol Section:
NCT00743405