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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01483469
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers as determined by medical history, physical examination, 12-lead ECG, and routine clinical laboratory measurements
* Age 18 to 65 years inclusive
* Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg
* Appropriate body size (less than 195 cm \[6 feet and 5 inches\]) in order to accommodate the whole body scanning
Exclusion Criteria:
* History of or presence of clinically significant psychiatric condition, as evaluated by a psychiatrist before enrolment
* History of head trauma with prolonged loss of consciousness (\>10 minutes) or any neurological condition or a history of migraine headaches
* Contraindications to MRI procedures (Part I, III and IV)
* Subjects suffering from claustrophobia or who would be unable to undergo magnetic resonance imaging (MRI) or PET scanning
* Positive pregnancy test at screening or on any day preceding a PET scan
* Lactating women
* Positive for hepatitis B, hepatitis C or HIV infection
* Any history of alcohol or drug abuse within the last 6 months
* Regular smoker or nicotine user (\>10 cigarettes per day)
* Participation in an investigational drug or device study within three months prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01483469
Study Brief:
Protocol Section:
NCT01483469