Phase I Drug Interaction Clinical Study of Polyphenon E
Data Collection
Prevention Study
Summary
Study start date: October 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants. Secondary * Determine the safety and tolerability of this drug in these participants. OUTLINE: This is an open-label study. Participants receive oral green tea extract (Polyphenon E) once daily for 4 weeks in the absence of unacceptable toxicity. Participants are followed for 2 weeks. PROJECTED ACCRUAL: A total of 44 participants will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
DISEASE CHARACTERISTICS: * Healthy individuals * Non-smokers * More than 1 year since smoking cessation * No concurrent smokers * No regular consumption of large amounts of alcohol * On average, ≤ 3 alcoholic drinks per week * Consumes \< 6 cups or glasses of tea per week PATIENT CHARACTERISTICS: Age * 18 and over Performance Status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL * AST or ALT ≤ 2 times normal * Alkaline phosphatase ≤ 2 times normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * Resting systolic blood pressure ≥ 100 mm Hg * No hypertension or hypercholesterolemia requiring unscheduled medical visits or changes in treatment within the past 3 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to refrain from tea and related products and oral herbal/botanical supplements during study participation * Willing to limit the consumption of cruciferous vegetables to ≤ once a week during study participation * Willing to refrain from caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) for 72 hours before, during, and for 8 hours after study drug administration * Willing to refrain from food items that affect drug or carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) for 72 hours before, during, and for 8 hours after study drug administration * No difficulty swallowing capsules or tablets * No metabolic disorder known to affect study drugs * No other serious acute or chronic disease (e.g., type I or II diabetes, cystic fibrosis, or active infection) * No known hypersensitivity to green tea or probe drugs (e.g., caffeine, dextromethorphan, losartan, or buspirone) * No invasive cancer (i.e., non-skin cancer) within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 3 months since prior participation in another clinical intervention study * No concurrent medications or supplements that are known P450 enzyme inducers or inhibitors
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, United StatesOpen Arizona Cancer Center at University of Arizona Health Sciences Center in Google Maps