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Diindolylmethane in Healthy Volunteers

2014-08-27 03:41:52 | BioPortfolio

Summary

RATIONALE: 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 person's body handles the drug.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers.

Description

OBJECTIVES:

Primary

- 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

- Determine the effect of BR-DIM™ on estrogen metabolites in urine and on activities of CYP2C9, CYP2D6, and P-glycoprotein/OATP.

- 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.

- Determine the safety and tolerability of single and multiple daily doses of this drug in healthy volunteers.

- Determine the pharmacokinetics of a single dose of BR-DIM™ and of the same dose after chronic daily dosing.

- Determine the effects of BR-DIM™ on activities of glutathione-S-transferase, 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.

PROJECTED ACCRUAL: A total of 14 participants will be accrued for this study.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

oral microencapsulated diindolylmethane, pharmacological study

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City
Kansas
United States
66160-7357

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:52-0400

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