Clinical trial · Interventional
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
NCT00450957CI-TRIAL-00017508completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lycopene | Dietary Supplement | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (high-dose lycopene)
- description
- 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.
- interventionNames
- Dietary Supplement: lycopene
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Arm II (low-dose lycopene)
- description
- 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
- interventionNames
- Dietary Supplement: lycopene
- Other: pharmacological study
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.