Clinical trial · Interventional
Diindolylmethane in Preventing Cancer in Healthy Volunteers
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)
NCT00784394CI-TRIAL-00025280completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diindolylmethane | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (diindolylmethane)
- description
- Participants receive a single dose of diindolylmethane PO on day 1.
- interventionNames
- Drug: diindolylmethane
- Other: pharmacological study
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Participants receive a single dose of placebo orally (PO) on day 1.
- interventionNames
- Other: placebo
- Other: pharmacological study
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.