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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00818194
Eligibility Criteria:
Inclusion Criteria:
* caucasian
* healthy with no history or current clinical findings of infection or disease of the following nature: cerebrovascular, neurologic, cardiovascular, endocrine, pulmonary, immunologic, metabolic, hematologic, diabetes mellitus, glucose intolerance, gout
* non-smoker and willing to abstain from alcohol consumption during the study
* agrees to use appropriate contraception during the study period until 3 months after the final study exam.
Exclusion Criteria:
* history of significant alcohol abuse or drug abuse within 1 year prior to the screening visit
* regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week)
* use of soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit Hepatitis B or C, HIV, history of cancer (excluding excised squamous or basal cell carcinoma)
* positive tuberculin skin test or prior TB infection
* known history of serious head injuries, seizures or any eating disorder
* received an investigational drug within 30 days prior to the first study drug administration
* known hypersensitivity/allergy to tacrolimus, cyclosporine, iothalamate iodine, para-aminohippuric acid, antibiotics or antifungals
* Body mass index (BMI) \<19 or \>27
* clinically significant history of psychiatric disease or a significant disability that prevents understanding or adherence to protocol
* renal dysfunction, serum creatinine or urine microalbumin above the normal age and gender-adjusted reference range of the local lab
* clinically significant abnormal liver function test indicative of impaired hepatic function
* received medications/herbal preparations that may affect the metabolism of tacrolimus or cyclosporine A within 1 month of the first study drug administration
* received any other prescription medication within 14 days prior to the first study drug administration or any over-the-counter product within 7 days prior to the first study drug administration, except for topical products without systemic absorption
* current GI condition known to affect GI motility and/or absorption
* donation of plasma (500 mL) within 7 days prior to the first study drug administration or donation/ loss of whole blood as follows: 50 mL to 499 mL within 30 days or more than 499 mL within 56 days prior to the first study drug administration
* clinically significant surgery within 4 weeks prior to the first study drug administration
* administration of steroids by injection within 12 weeks prior to the first study drug administration
* administration of any live vaccine within 7 days prior to the first study drug administration
* travel in areas where TB is endemic within 8 weeks prior to the TB skin test performed at the screening visit
* hemoglobin \<140 g/L
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00818194
Study Brief:
Protocol Section:
NCT00818194