NCT00100958

Indole-3-Carbinol in Preventing Cancer in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer. PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of indole-3-carbinol in healthy participants. * Determine the safety and tolerability of this drug in these participants. * Determine the pharmacokinetics of this drug in these participants. Secondary * Determine the effects of this drug on selected markers of sexual function in these participants. * Determine the effects of this drug on markers of susceptibility to cancer in these participants. OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms. * Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1. * Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD. Participants are followed on days 2, 3, and 6. PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	indole-3-carbinol

Timeline

• Start date: 2004-11-01
• First posted: 2005-01-10
• Last updated: 2008-07-24

Locations

1 site across 1 country: United States