NCT00784394

Diindolylmethane in Preventing Cancer in Healthy Volunteers

Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This phase I clinical trial studies the side effects and best dose of diindolylmethane in preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people who eat a chemical that is normally found in vegetables, including cabbage, broccoli, Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development of cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are safe and well- tolerated. II. To determine the pharmacokinetics of these single oral doses of DIM. OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms. ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1. ARM II: Participants receive a single dose of placebo orally (PO) on day 1. After completion of study treatment, participants are followed up on days 2, 3, and 6.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	diindolylmethane	Given PO
OTHER	placebo	Given PO
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2004-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-11-04
• Last updated: 2016-12-29

Locations

1 site across 1 country: United States