Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
- 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.
- Determine the effects of this drug on selected markers of sexual function in these
- Determine the effects of this drug on markers of susceptibility to cancer in these
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Gregory Reed, PhD
University of Kansas
United States: Federal Government
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|