Clinical trial NCT00450957: Lycopene in Healthy Male Participants
Official title: Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, no Evidence of Disease
Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 lycopene, a substance found in tomatoes, may prevent prostate cancer.

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 participants.

III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.

OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.

Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.

PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.

Eligibility criteria: 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

Primary outcomes:
measure: Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
timeFrame: 2 weeks
measure: Safety according to NCI CTC version 3.0
timeFrame: 12 weeks
measure: Pharmacokinetics
timeFrame: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Keith Rodvold
role: PRINCIPAL_INVESTIGATOR
References: