NCT00100958已完成1 期
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Healthy participants
- •Non-smoker
- •No drug abuse, as determined by urine cotinine and baseline drug screen
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •At least 12 months
- •Hematopoietic
- •Absolute granulocyte count > 1,500/mm^3
- •Hemoglobin > 10 g/dL
- •Bilirubin < 1.8 mg/dL
- •AST and ALT < 110 U/L
- •Alkaline phosphatase < 300 U/L
- •Creatinine < 2.0 mg/dL
- •Albumin > 3.0 g/dL
- •No asthma
- •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
- •Dizziness
- •Blurred vision
- •Rhinorrhea
- •Abdominal pain
- •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
- •Not specified
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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