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Clinical Trials/NCT00093561
NCT00093561CompletedPhase 1

Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age

University of Illinois at Chicago2 sites in 1 countryStarted: August 1, 2004Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
2
Primary Endpoint
Toxicity by blood chemistries and patient histories at 4 weeks after treatment

Study Overview

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

Detailed Description

OBJECTIVES:

  • Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.
  • Determine the pharmacokinetics of this agent in these participants.
  • Determine the dose range of this agent in these participants.

OUTLINE: This is a dose-escalation study.

Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.

Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity.

Study Design

Study Type
Interventional
Primary Purpose
Prevention

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • DISEASE CHARACTERISTICS:
  • Healthy participants in good medical condition
  • No chronic medical conditions
  • No regular use of prescription medications
  • No evidence of psychiatric disorder
  • Non-smoker
  • Former smokers allowed provided they have not smoked within the past 3 months
  • No history of alcohol abuse
  • Serum lycopene concentration < 700 nM
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Karnofsky 100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Hemoglobin ≥ 13.0 g/dL
  • WBC ≥ 4,000/mm^3
  • Platelet count 150,000-400,000/mm^3
  • AST and ALT ≤ 75 U/L
  • Bilirubin ≤ 2.0 mg/dL
  • No liver disease
  • Creatinine ≤ 1.5 mg/dL
  • No renal disease
  • Cardiovascular
  • No cardiovascular disease
  • No abnormal EKG
  • Within 15% of ideal body weight
  • No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
  • No alcohol consumption within the past 72 hours
  • No allergy to tomato-based products
  • No history of cancer
  • No diabetes mellitus
  • No other illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Not specified
  • At least 4 weeks since prior experimental drugs
  • More than 14 days since prior prescription drugs
  • No concurrent participation in another experimental trial
  • No concurrent prescription drugs

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Toxicity by blood chemistries and patient histories at 4 weeks after treatment

Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment

Secondary Outcomes

  • Define dose range by blood lycopene concentrations at 4 weeks after treatment

Investigators

Sponsor Class
Other

Study Sites (2)

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