Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392652
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2006-10-25
Brief Title:
Diindolylmethane in Healthy Volunteers
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 1 Multiple-Dose Safety Pharmacokinetic and Drug Interaction Clinical Study of Nutritional-Grade Absorption-Enhanced DIM BR-DIM
Status:
COMPLETED
Status Verified Date:
2016-12
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 diindolylmethane in healthy volunteers Chemoprevention is the use of certain drugs or substances to keep cancer from forming growing or coming back The use of diindolylmethane may keep cancer from forming Collecting and storing samples of blood and urine from healthy volunteers to study in the laboratory may help doctors learn more about the way a persons body handles the drug
Detailed Description:
PRIMARY OBJECTIVES
I Determine the effect of multiple daily dosing with nutritional-grade absorption-enhanced diindolylmethane BR-DIM on the disposition of probe drugs metabolized by cytochrome P4501A2 CYP1A2 and CYP3A4 in healthy volunteers
SECONDARY OBJECTIVES
I Determine the effect of multiple daily doses of BR-DIM on estrogen metabolites in urine and on activities of CYP2C9 CYP2D6 and P-glycoproteinOATP
II Determine the effect of a single dose of BR-DIM on the disposition of probe drugs that are metabolized or transported by CYP1A2 CYP2C9 CYP2D6 CYP3A4 and P-glycoprotein P-go
III Determine the safety and tolerability of single and multiple daily doses of BR-DIM
IV Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after chronic daily dosing
V Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after chronic daily dosing
TERTIARY OBJECTIVES
I To determine effects of BR-DIM on activities of glutathione-S-transferase GST a phase 2 enzyme in lymphocytes
OUTLINE This is a randomized double-blind study Participants are stratified according to gender Participants are randomized to 1 of 2 intervention arms
Arm I Participants receive low-dose oral diindolylmethane BR-DIM twice daily for 4 weeks
Arm II Participants receive high-dose oral BR-DIM twice daily for 4 weeks
In both arms participants receive an oral probe-drug cocktail comprising caffeine CYP1A2 dextromethorphan CYP2D6 buspirone CYP3A4 losartan CYP2C9 and fexofenadine P-glycoprotein before randomization and after the first and last dose of BR-DIM
Blood and urine are collected periodically for pharmacokinetic profiles of BR-DIM and probe drugs
After completion of study intervention participants are followed at 1 week
I Determine the effect of multiple daily dosing with nutritional-grade absorption-enhanced diindolylmethane BR-DIM on the disposition of probe drugs metabolized by cytochrome P4501A2 CYP1A2 and CYP3A4 in healthy volunteers
SECONDARY OBJECTIVES
I Determine the effect of multiple daily doses of BR-DIM on estrogen metabolites in urine and on activities of CYP2C9 CYP2D6 and P-glycoproteinOATP
II Determine the effect of a single dose of BR-DIM on the disposition of probe drugs that are metabolized or transported by CYP1A2 CYP2C9 CYP2D6 CYP3A4 and P-glycoprotein P-go
III Determine the safety and tolerability of single and multiple daily doses of BR-DIM
IV Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after chronic daily dosing
V Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after chronic daily dosing
TERTIARY OBJECTIVES
I To determine effects of BR-DIM on activities of glutathione-S-transferase GST a phase 2 enzyme in lymphocytes
OUTLINE This is a randomized double-blind study Participants are stratified according to gender Participants are randomized to 1 of 2 intervention arms
Arm I Participants receive low-dose oral diindolylmethane BR-DIM twice daily for 4 weeks
Arm II Participants receive high-dose oral BR-DIM twice daily for 4 weeks
In both arms participants receive an oral probe-drug cocktail comprising caffeine CYP1A2 dextromethorphan CYP2D6 buspirone CYP3A4 losartan CYP2C9 and fexofenadine P-glycoprotein before randomization and after the first and last dose of BR-DIM
Blood and urine are collected periodically for pharmacokinetic profiles of BR-DIM and probe drugs
After completion of study intervention participants are followed at 1 week
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 |
|---|---|---|---|
| N01CN35008 | OTHER | US NIH GrantContract Award Numbe | None |
| NCI-2009-00867 | REGISTRY | None | None |
| CDR0000511393 | None | None | None |
| HSC 9139 | None | None | None |
| HSC 9139 | OTHER | None | None |
| N01-CN-35008-3 | OTHER | None | None |