Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT00100958
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00100958
Study Brief:
Protocol Section:
NCT00100958