Status:
COMPLETED
Diindolylmethane in Healthy Volunteers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Healthy, no Evidence of Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 formin...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the effect of multiple daily dosing with nutritional-grade, absorption-enhanced diindolylmethane (BR-DIM) on the disposition of probe drugs metabolized by cytochrome ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00392652
Start Date
November 1 2006
End Date
October 1 2009
Last Update
December 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160