Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Normal healthy males judged to be in good medical condition based on history and
physical exam confirming the absence of chronic medical conditions

- Baseline serum lycopene less than 600 nM

PATIENT CHARACTERISTICS:

Age:

- 18 to 45

Performance status:

- Karnofsky 100%

Life expectancy:

- Not specified

Hematopoietic:

- Hematologic function normal

Hepatic:

- Liver function normal

- No hepatic disease

Renal:

- Kidney function normal

- No renal disease

Cardiovascular:

- No hypertension requiring medication

- No cardiovascular disease

- Normal EKG

Other:

- No evidence of a psychiatric disorder

- Must be within 15% of ideal body weight based on standard weight tables

- No history of smoking within the past 3 months

- At least 72 hours since prior alcohol consumption and no history of alcohol abuse

- No history of gastrointestinal malabsorption or any other condition that could affect
drug absorption

- No allergy to tomato based products

- No active malignancy at any site

- No illness that would pose a threat or additional risk (e.g., thyroid disease,
diabetes mellitus)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- At least 14 days since prior prescription drugs

- No concurrent regular prescription medications

- At least 30 days since other prior experimental drugs

- No concurrent participation in any other experimental trial