Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 5:03 AM
Study NCT ID:
NCT00450957
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2007-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lycopene in Healthy Male Participants
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: