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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
University of Kansas Medical Center
Kansas City, Kansas, United States
Maximum tolerated dose (MTD), defined as the highest dose at which no grade 2 or higher toxicities are seen
Frequencies and percents will be used to summarize the toxicities seen at each dose level and overall. Descriptive statistics will be calculated on all variables of interest: frequencies and percentages will be used to summarize categorical variables and medians, and ranges will summarize quantitative variables.
Time frame: Up to day 6
Pharmacokinetics of diindolylmethane
Pharmacokinetic parameters such as half-life, maximum concentration (Cmax), time of Cmax (Tmax), and area under the concentration-time curve (AUC) will be calculated for all subjects who complete the study. It is anticipated that a one-compartment elimination model will fit the data. These parameters will be summarized at each dose and overall with median and ranges.
Time frame: Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Correlative studies
Ancillary studies