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
18 Years
55 Years
Male
Healthy, no Evidence of Disease, Prostate Cancer
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 Illinois | Chicago, Illinois 60612 |
