Lycopene in Healthy Male Participants

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450957
• Other study ID #: NCI-2012-02709
• Secondary ID: UIC-2006-0853CDR
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2007
• Last updated: April 14, 2015
• Start date: October 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease
• Prostate Cancer

Intervention

Dietary Supplement:
• lycopene
Given orally

Other:
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0		2 weeks	Yes
Primary	Safety according to NCI CTC version 3.0		12 weeks	Yes
Primary	Pharmacokinetics		At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours	No