NCT00392652

Phase 1 Multiple-Dose Safety, Pharmacokinetic, and Drug Interaction Clinical Study of Nutritional-Grade, Absorption-Enhanced DIM (BR-DIM)

Completed Phase 1 Last updated 28 December 2016

What this trial tests

Phase 1 trial testing oral microencapsulated diindolylmethane in Healthy, no Evidence of Disease in 14 participants. Completed in 1 October 2009.

Timeline

1 November 2006

Primary endpoint
1 October 2008

1 October 2009

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	14
Start date	1 November 2006
Primary completion	1 October 2008
Estimated completion	1 October 2009
Sites	1 location across United States

Drugs / interventions tested

• oral microencapsulated diindolylmethane — full drug profile →

Conditions studied

• Healthy, no Evidence of Disease — all drugs for Healthy, no Evidence of Disease →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 70, any sex, with Healthy, no Evidence of Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Effect of diindolylmethane (BR-DIM) on activities of CYP3A4 and CYP1A2
  Time frame: Up to 1 week
  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. Paired t-tests will be used to compare enzyme levels post-pre at each dose. Analysis of covariance will be used to determine if there is a dose effect on enzyme levels, using the baseline v
• Grade 2 or higher toxicities, graded using NCI CTC version 2.0
  Time frame: Up to 1 week
  A one-sided binomial test will be used. 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.
• Steady-state pharmacokinetic parameters such as half-life, Cmax, Tmax, and AUC
  Time frame: Up to 1 week
  Pharmacokinetic parameters between pre- and post-menopausal women will be compared using the Wilcoxon rank-sum test.

Sponsor's own description

This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer from forming. Collecting and storing samples of blood and urine from healthy volunteers to study in the laboratory may help doctors learn more about the way a person's body handles the drug.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chemopreventive properties of 3,3'-diindolylmethane in breast cancer: evidence from experimental and human studies.
   Thomson CA, Ho E, Strom MB. · · 2016 · cited 72× · PMID 27261275 · DOI 10.1093/nutrit/nuw010
2. DNA-Methyltransferase 1 Induces Dedifferentiation of Pancreatic Cancer Cells through Silencing of Krüppel-Like Factor 4 Expression.
   Xie VK, Li Z, Yan Y, Jia Z, et al · · 2017 · cited 43× · PMID 28659310 · DOI 10.1158/1078-0432.ccr-17-0387