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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT01250535
Eligibility Criteria:
Inclusion Criteria:
* Normal baseline clinical laboratory results including coagulation panel (prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT)), liver function tests (ALT, AST, alkaline phosphatase and total bilirubin), kidney function tests (serum creatinine and BUN), lipid panel (cholesterol, LDL-C, HDL-C, and triglycerides), and blood creatine kinase
* Minimum weight of 110 lbs and minimum hemoglobin level at 12.5 g/dL
* Ability to understand the informed consent form
* Willing to abstain from grapefruit products, alcohol, and physical contact sports
Exclusion Criteria:
* History of intolerance, allergy, or hypersensitivity to study drugs warfarin and lovastatin or any substances contained in the medication
* History of clotting disorders, stroke, hypertension, anemia, renal insufficiency, hepatic dysfunction, platelet dysfunction, gastrointestinal bleeding, or any recent bleeding episode or trauma within 6 months
* History of significant medical conditions that the study physician believes would increase risk (e.g., additional bleeding disorders)
* Genotype non-homozygous for CYP2C9\*1 or genotype VKORC1-1639AA
* History of significant alcohol abuse and/or illicit drug use
* Tobacco use within the month preceding the study
* Woman who is pregnant or breastfeeding
* Women who are unable to maintain adequate birth control during the study
* Post-menopausal women on estrogen replacement
* Chronic statin or warfarin use
* Taking concomitant medications, both prescription and non-prescription (including herbal products, over-the-counter medications, and multivitamins), known to alter lovastatin, warfarin, or vitamin K blood levels (women stabilized on hormonal methods of birth control will be allowed to participate, and subjects stabilized on antidepressant medications will be allowed to participate)
* Recent use of antibacterial antibiotics
* Recent blood donation or participation in other clinical studies within past 8 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01250535
Study Brief:
Protocol Section:
NCT01250535