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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


Phase 1
18 Years
55 Years
Open (Enrolling)
Male
Healthy, no Evidence of Disease, Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Keith Rodvold

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02709

NCT ID:

NCT00450957

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of IllinoisChicago, Illinois  60612