Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450957
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2007-03-20
Brief Title:
Lycopene in Healthy Male Participants
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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 IIIII 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 IIIII 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN85081 | OTHER_GRANT | US NIH GrantContract Award Number | None |
| UIC-2006-0853 | None | None | None |
| CDR0000536181 | None | None | None |