Diindolylmethane in Preventing Cancer in Healthy Volunteers

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.

Inclusion Criteria:

- Non-smokers and non-users of abuse drugs as confirmed by urine cotinine (Accutest
NicoMeter Urine Professional strip or equivalent test) and drug screen at visit 1

- Free of acute, unstable, chronic or recurring medical conditions based on history,
physical examination, laboratory tests; the laboratory tests to be performed will be:
blood serum chemistry screen to include comprehensive metabolic panel (glucose,
creatinine, urea nitrogen [blood urea nitrogen (BUN)], sodium, potassium, chloride,
calcium, total bilirubin, protein, albumin, globulin, cholesterol and the enzymes
alkaline phosphatase, aspartate aminotransferase [AST], and alanine aminotransferase
[ALT]) and lipid panel (total, low density lipoprotein [LDL] and high density
lipoprotein [HDL] cholesterol and triglycerides); complete blood count including
differential and platelet count; prothrombin time; and routine urinalysis; values for
laboratory tests must be within the ranges below grade 2 of Common Toxicity Criteria
(CTC) and/or as specified below:

- Hemoglobin > 10 g/dL

- Absolute granulocyte count > 1500/ìL

- Creatinine < 2.0 mg/dl

- Albumin > 3.0 g/dl

- Bilirubin < 1.8 mg/dl

- AST < 110 U/l

- ALT < 110 U/l

- Alkaline phosphatase < 300 U/l

- Subjects must weigh +/- 20% of ideal body weight by the Metropolitan Life tables

- Men or women who are strict vegetarians or who eat more than 3 medium servings (1/2
cup each) of cruciferous vegetables per week will be excluded; those who stop
ingesting cruciferous vegetables >= 14 days and alcohol >= 7 days before starting DIM
and agree to refrain from taking them for the duration of the study will not be
excluded; cruciferous vegetables include broccoli, cabbage (including coleslaw),
cauliflower, bok-choy, Brussels sprouts, collards, kale, kohlrabi, mustard greens,
rutabaga, turnip, and watercress; participants will be asked to complete a brief diet
questionnaire listing these vegetables to assess these criteria; caffeine- and
grapefruit-containing foods and beverages are to be avoided for at least 48 hours
before visit 2 (DIM dosing)

Exclusion Criteria:

- Subjects with serious drug allergies or other serious intolerance or allergies will
be excluded; those with mild seasonal allergies will be accepted

- Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision,
insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or
similar conditions

- Subjects with a serious acute or chronic illness (diabetes, arthritis, asthma, etc.)
or requiring chronic drug therapy, who continuously take supplements or have taken an
investigational drug within the past three months

- Subjects who have evidence of an active malignancy or have received chemotherapy,
and/or antiestrogen therapy

- Subjects who have a life expectancy of < 12 months

- Subjects who have regularly taken over the past 21 days any concomitant medications,
herbal products, dietary supplements or vitamins; women taking oral contraceptives
will be accepted; women who are pregnant (positive urine human chorionic gonadotropin
[hCG] at visit 2) or lactating will be excluded