Status:
COMPLETED
Lycopene in Healthy Male Participants
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Healthy, no Evidence of Disease
Prostate Cancer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of l...
Detailed Description
OBJECTIVES: I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants. II. Compare the pharmacokinetics of 2 different doses of this drug in these partici...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy volunteers judged to be in good medical condition based on history and physical exam
- Karnofsky performance status 100%
- AST and ALT ≤ 75 IU/L
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Hemoglobin ≥ 13.0 g/dL
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
- Must be within height and weight standards identified by Metropolitan Life scales
- Nonsmoker (for ≥ 3 months)
- No history of alcohol abuse
- No history of gastrointestinal malabsorption or other condition that could affect drug absorption
- No history of a psychiatric condition
- No chronic medical condition
- No active history of any of the following:
- Cancer
- Liver disease
- Cardiovascular disease
- Renal disease
- Diabetes mellitus
- Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
- No allergy to tomato-based products
- No lycopene in the diet for ≥ 14 days
- At least 4 weeks since prior and no other concurrent experimental medications
- No concurrent participation in another experimental study
- No concurrent use of regular prescription medication or over-the-counter medications
- No concurrent vitamin, mineral, or herbal supplements
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00450957
Start Date
October 1 2006
End Date
November 1 2007
Last Update
April 15 2015
Active Locations (1)
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1
University of Illinois
Chicago, Illinois, United States, 60612