Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.
详细描述
OBJECTIVES:
- Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer.
- Determine the pharmacokinetics of this regimen in this population.
- Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population.
OUTLINE: This is a dose-escalation study.
Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days.
Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions
- •Baseline serum lycopene less than 600 nM
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hematologic function normal
- •Liver function normal
- •No hepatic disease
- •Kidney function normal
- •No renal disease
- •Cardiovascular:
- •No hypertension requiring medication
- •No cardiovascular disease
- •Normal EKG
- •No evidence of a psychiatric disorder
- •Must be within 15% of ideal body weight based on standard weight tables
- •No history of smoking within the past 3 months
- •At least 72 hours since prior alcohol consumption and no history of alcohol abuse
- •No history of gastrointestinal malabsorption or any other condition that could affect drug absorption
- •No allergy to tomato based products
- •No active malignancy at any site
- •No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •At least 14 days since prior prescription drugs
- •No concurrent regular prescription medications
- •At least 30 days since other prior experimental drugs
- •No concurrent participation in any other experimental trial
排除标准
- 未提供