- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450957
Lycopene in Healthy Male Participants
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I (high-dose lycopene)
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.
|
Correlative studies
Other Names:
Given orally
Other Names:
|
EXPERIMENTAL: Arm II (low-dose lycopene)
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
|
Correlative studies
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Time Frame: 2 weeks
|
2 weeks
|
Safety according to NCI CTC version 3.0
Time Frame: 12 weeks
|
12 weeks
|
Pharmacokinetics
Time Frame: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
|
At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Rodvold, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Radiation-Protective Agents
- Lycopene
Other Study ID Numbers
- NCI-2012-02709
- UIC-2006-0853
- CDR0000536181
- N01CN85081 (OTHER_GRANT: US NIH Grant/Contract Award Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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