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Diindolylmethane in Healthy Nonsmokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00784394
First received: November 1, 2008
Last updated: May 15, 2013
Last verified: October 2008
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers.


Condition Intervention Phase
Healthy, no Evidence of Disease
 Drug: oral microencapsulated diindolylmethane
Other: gas chromatography
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
Other: pharmacological study
 Phase 1

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and toxicity of oral microencapsulated diindolylmethane (DIM) as assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
  • Maximum-tolerated dose of DIM [ Designated as safety issue: Yes ]
  • Pharmacokinetics of DIM [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2004
Detailed Description:

OBJECTIVES:

Primary

  • To determine single oral doses of microencapsulated diindolylmethane (DIM) that are safe and well-tolerated in healthy volunteers.
  • To determine the pharmacokinetics of DIM in these participants.
  • To determine the effect of multiple daily dosing with DIM on the disposition of probe drugs metabolized by cytochrome P4501A2 (CYP1A2) and CYP3A4 in these participants.

Secondary

  • To determine the effect of multiple daily doses of DIM on estrogen metabolites in urine, and on activities of CYP2C9, CYP2D6, and P-glycoprotein (P-gp)/OATP (Organic Anion Transport Protein) in these participants.
  • To determine the effect of a single dose of DIM on the disposition of probe drugs that are metabolized or transported by CYP1A2, CYP2C9, CYP2D6, CYP3A4, and P-gp in these participants.
  • To determine the safety and tolerability of single and multiple daily doses of DIM.
  • To determine the pharmacokinetics of a single dose of DIM and of the same dose after chronic daily dosing.

Tertiary

  • To determine effects of DIM on activities of glutathione-S-transferase (GST) and quinone reductase (NQO1), and phase 2 enzymes in lymphocytes.
  • To determine effects of multiple daily doses of DIM on markers of susceptibility to cancer, including serum insulin-like growth factor-1 (IGF-1), and serum IGF-binding protein-3 (IGFBP-3).
  • To determine effects of multiple daily doses of DIM on selected markers of sexual function: estradiol, progesterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin (SHBG), and basal body temperature in women and testosterone, LH, and SHBG in men.

OUTLINE: This is a dose-escalation, placebo-controlled study of oral microencapsulated diindolylmethane (DIM).

Participants receive a single dose of oral DIM daily for 6 days provided there is no unacceptable toxicity. In each dosing cohort, 1 participant is randomized to receive the matching placebo and 3 patients receive DIM.

Blood and urine are collected before administering DIM and serially during the following 24 hours for pharmacokinetic studies. Plasma is analyzed by liquid chromatography/mass spectroscopy and urine by gas chromatography/mass spectroscopy.

After completion of the study, participants are followed periodically for 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy, non-smoking volunteers

    • Non-smoker status confirmed by urine cotinine assay at baseline (Accutest NicoMeter Urine Professional strip or equivalent test)

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 12 months
  • Hemoglobin > 10 g/dL
  • Absolute Granulocyte Count > 1,500/μL
  • 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
  • Not pregnant or nursing
  • Negative pregnancy test
  • Within +/- 20% of ideal body weight by the Metropolitan Life tables
  • Strict vegetarians are excluded
  • No serious drug allergies or other serious intolerance or allergies (mild seasonal allergies are allowed)
  • No chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions
  • No serious acute or chronic illness (diabetes, arthritis, asthma, etc.) requiring chronic drug therapy
  • No active malignancy

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No investigational drug within the past three months
  • At least 14 days since prior and no more than 3 concurrent medium servings (½ cup each) of cruciferous vegetable (i.e., broccoli, cabbage [including coleslaw], cauliflower, bok-choy, brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress) per week
  • At least 7 days since prior and no concurrent alcohol intake
  • No caffeine and grapefruit-containing foods and beverages for at least 48 hours before dosing
  • No regular concomitant medications, herbal products, dietary supplements or high dose vitamins over the past 21 days
  • No concurrent medications other than oral contraceptives or hormones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784394

Sponsors and Collaborators
University of Kansas
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aryeh Hurwitz, MD University of Kansas
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00784394     History of Changes
Other Study ID Numbers: CDR0000617334, KUMC-HSC-9139
Study First Received: November 1, 2008
Last Updated: May 15, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
healthy, no evidence of disease

ClinicalTrials.gov processed this record on May 19, 2013