Diindolylmethane in Healthy Volunteers

NCT00392652 | Completed Phase 1

• 5 other identifiers: NCI-2009-00867CDR0000511393HSC # 9139N01-CN-35008-3N01CN35008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (3)

• Effect of diindolylmethane (BR-DIM) on activities of CYP3A4 and CYP1A2

  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 values as a covariate. If there is no dose effect, the seven subjects at each dose will be pooled which will provide an increase power to detect meaningful changes in enzyme levels.

  Up to 1 week

• Grade 2 or higher toxicities, graded using NCI CTC version 2.0

  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.

  Up to 1 week

• Steady-state pharmacokinetic parameters such as half-life, Cmax, Tmax, and AUC

  Pharmacokinetic parameters between pre- and post-menopausal women will be compared using the Wilcoxon rank-sum test.

  Up to 1 week

Secondary Outcomes (2)

• Drug metabolizing enzyme values (CYP2C9, CYP2D6, P-glycoprotein/OATP, and glutathione-S-transferase)

  Up to 1 week

• 2/16 alpha OHE ratio in urine

  Up to 1 month

Study Arms (2)

Arm I (low-dose oral diindolylmethane)

EXPERIMENTAL

Participants receive low-dose oral diindolylmethane (BR-DIM) twice daily for 4 weeks.

Drug: oral microencapsulated diindolylmethane

Arm II (high-dose oral diinolylmethane)

EXPERIMENTAL

Participants receive high-dose oral BR-DIM twice daily for 4 weeks.

Drug: oral microencapsulated diindolylmethane

Interventions

oral microencapsulated diindolylmethane DRUG

Given PO

Also known as: BioResponse DIM, BR-DIM

Arm I (low-dose oral diindolylmethane); Arm II (high-dose oral diinolylmethane)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria: * Healthy men and women * Nonsmoker confirmed by urine cotinine test * No active malignancy * Life expectancy \>= 12 months * Hemoglobin \> 10 g/dL * Absolute granulocyte count \> 1,500/mm\^3 * Creatinine \< 2.0 mg/dL * Albumin \> 3.0 g/dL * Bilirubin \< 1.8 mg/dL * AST and ALT \< 110 U/L * Alkaline phosphatase \< 300 U/L * Body mass index =\< 30 * Not pregnant or nursing * Negative pregnancy test * Fertile participants must use effective nonhormonal contraception * No acute, unstable, chronic, or recurring medical conditions * No strict vegetarians or consumption of \> 3 medium servings (1/2 cup each) of cruciferous vegetables per week * Participants who have stopped eating cruciferous vegetables within the past 2 weeks and agree to refrain from eating them for the duration of the study are eligible * Cruciferous vegetables include broccoli, cabbage (including coleslaw), cauliflower, bok-choy, brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress * No serious drug allergies or other serious intolerance or allergies * Mild seasonal allergies allowed * No chronic conditions, including headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, menopausal hot flashes/night sweats, or clinically significant premenstrual syndrome * No serious acute or chronic illness * No requirement for chronic drug therapy * No alcohol ingestion within 48 hours of study treatment * No investigational drugs within the past 3 months * No prior chemotherapy * No concurrent regular medications or hormones * No recent change in medications or dosage of medications * No concurrent regular supplements or vitamins * No concurrent over-the-counter medications * No concurrent grapefruit or its juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Reed Greg

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2009
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)