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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00531193
Eligibility Criteria:
Inclusion Criteria:
* BMI between 18.0 and 29.0 kg/m2
* Willing to abstain from caffeine-containing products from 1 week prior to dosing until discharge from unit.
* Willing and able to practice effective contraception until 2 months following last dose of study drug.
Exclusion Criteria:
* History of severe allergic reactions or clinically significant allergies.
* History of malignancy, excluding adequately treated basal cell carcinoma.
* History of any clinically significant disease.
* History of claustrophobia or any condition incompatible with MRI/PET scanning.
* History of any exposure to ionizing radiation, with the exception of dental x-rays, within the 12 months prior to dosing.
* Serious infection within the 4 weeks prior to dosing.
* HbA1c \> 6%, positive for Hepatitis C or Hepatitis B, presence of HIV or known exposure to HIV, positive G6PD assay, or any other clinically significant abnormal laboratory parameters at Screening.
* Abnormal supine or standing blood pressure or orthostatic hypotension.
* Any prior treatment with antipsychotic medications, dopamine antagonists, or dopaminergic agonists.
* Treatment with any other investigational drug within 3 months prior to dosing.
* Treatment with any prescription medications within 4 weeks prior to dosing.
* History of drug or alcohol abuse within 1 year prior to dosing.
* Current smoker or any tobacco use within 3 months prior to dosing.
* Heavy caffeine consumption within 4 weeks prior to dosing.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00531193
Study Brief:
Protocol Section:
NCT00531193