Spots Global Cancer Trial Database for Diindolylmethane in Preventing Cancer in Healthy Volunteers

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Trial Identification

Brief Title: Diindolylmethane in Preventing Cancer in Healthy Volunteers

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

Study ID: NCT00784394

Conditions

Healthy, no Evidence of Disease

Interventions

diindolylmethane

placebo

pharmacological study

laboratory biomarker analysis

quality-of-life assessment

Study Description

Brief 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.