NCT00392652

Diindolylmethane in Healthy Volunteers

Phase 1 Multiple-Dose Safety, Pharmacokinetic, and Drug Interaction Clinical Study of Nutritional-Grade, Absorption-Enhanced DIM (BR-DIM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 person's 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-glycoprotein/OATP. 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.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	oral microencapsulated diindolylmethane	Given PO

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-10-01
• Completion: 2009-10-01
• First posted: 2006-10-26
• Last updated: 2016-12-29

Locations

1 site across 1 country: United States