Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
18 Years
70 Years
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
- Determine the safety and tolerability of this drug in these participants.
- Determine the pharmacokinetics of this drug in these participants.
Secondary
- Determine the effects of this drug on selected markers of sexual function in these
participants.
- Determine the effects of this drug on markers of susceptibility to cancer in these
participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study.
Participants at each dose level are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
- Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3
participants receive escalating doses of indole-3-carbinol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3
participants experiences dose-limiting toxicity. An additional cohort of 3 participants
is treated at the MTD.
Participants are followed on days 2, 3, and 6.
PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued
for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Healthy participants
- Non-smoker
- No drug abuse, as determined by urine cotinine and baseline drug screen
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- Not specified
Life expectancy
- At least 12 months
Hematopoietic
- Absolute granulocyte count > 1,500/mm^3
- Hemoglobin > 10 g/dL
Hepatic
- Bilirubin < 1.8 mg/dL
- AST and ALT < 110 U/L
- Alkaline phosphatase < 300 U/L
Renal
- Creatinine < 2.0 mg/dL
- Albumin > 3.0 g/dL
Pulmonary
- No asthma
Other
- Not pregnant or nursing
- Negative pregnancy test
- Weight within 20% of ideal body weight by the Metropolitan Life table
- No serious drug allergies
- No arthritis
- No acute, unstable, chronic, or recurring medical condition
- No strict vegetarians
- No diabetes
- No evidence of an active malignancy
- No other serious intolerance or allergies
- Mild seasonal allergies allowed
- No other serious acute or chronic illness
- None of the following chronic conditions:
- Headaches
- Dysphoria
- Fatigue
- Dizziness
- Blurred vision
- Insomnia
- Rhinorrhea
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Constipation
- Premenstrual syndrome
- Cessation of menses within the past 10 days (menstruating women only)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Concurrent oral contraceptives allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 21 days since prior medications, herbal products, dietary supplements, or
high-dose vitamins
- More than 3 months since prior investigational drugs
- At least 14 days since prior and no concurrent ingestion of cruciferous vegetables,
including any of the following:
- Broccoli
- Cabbage, including coleslaw
- Cauliflower
- Bok-choy
- Brussels sprouts
- Collards
- Kale
- Kohlrabi
- Mustard greens
- Rutabaga
- Turnip
- Watercress
- At least 7 days since prior and no concurrent alcohol consumption
- At least 48 hours since prior ingestion of grapefruit-containing foods and beverages
- No concurrent chronic drug therapy
- No other concurrent supplements, including dietary supplements, vitamins, herbal
products, or over-the-counter medications
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Gregory Reed, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Kansas
Authority:
United States: Federal Government
Study ID:
CDR0000406002
NCT ID:
NCT00100958
Start Date:
November 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
