Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 2
- Primary Endpoint
- Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Study Overview
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.
Detailed Description
OBJECTIVES:
- Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.
- Determine the pharmacokinetics of this agent in these participants.
- Determine the dose range of this agent in these participants.
OUTLINE: This is a dose-escalation study.
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.
Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Healthy participants in good medical condition
- •No chronic medical conditions
- •No regular use of prescription medications
- •No evidence of psychiatric disorder
- •Non-smoker
- •Former smokers allowed provided they have not smoked within the past 3 months
- •No history of alcohol abuse
- •Serum lycopene concentration < 700 nM
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ 13.0 g/dL
- •WBC ≥ 4,000/mm^3
- •Platelet count 150,000-400,000/mm^3
- •AST and ALT ≤ 75 U/L
- •Bilirubin ≤ 2.0 mg/dL
- •No liver disease
- •Creatinine ≤ 1.5 mg/dL
- •No renal disease
- •Cardiovascular
- •No cardiovascular disease
- •No abnormal EKG
- •Within 15% of ideal body weight
- •No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
- •No alcohol consumption within the past 72 hours
- •No allergy to tomato-based products
- •No history of cancer
- •No diabetes mellitus
- •No other illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 4 weeks since prior experimental drugs
- •More than 14 days since prior prescription drugs
- •No concurrent participation in another experimental trial
- •No concurrent prescription drugs
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
Secondary Outcomes
- Define dose range by blood lycopene concentrations at 4 weeks after treatment