Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
研究概览
简要总结
This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
详细描述
OBJECTIVES:
I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.
III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers judged to be in good medical condition based on history and physical exam
- •Karnofsky performance status 100%
- •AST and ALT ≤ 75 IU/L
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 1.5 mg/dL
- •Hemoglobin ≥ 13.0 g/dL
- •WBC ≥ 4,000/mm³
- •Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
- •Must be within height and weight standards identified by Metropolitan Life scales
- •Nonsmoker (for ≥ 3 months)
- •No history of alcohol abuse
- •No history of gastrointestinal malabsorption or other condition that could affect drug absorption
- •No history of a psychiatric condition
- •No chronic medical condition
- •No active history of any of the following:
- •Liver disease
- •Cardiovascular disease
- •Renal disease
- •Diabetes mellitus
- •Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
- •No allergy to tomato-based products
- •No lycopene in the diet for ≥ 14 days
- •At least 4 weeks since prior and no other concurrent experimental medications
- •No concurrent participation in another experimental study
- •No concurrent use of regular prescription medication or over-the-counter medications
- •No concurrent vitamin, mineral, or herbal supplements
排除标准
- 未提供
结局指标
主要结局
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
时间窗: 2 weeks
Safety according to NCI CTC version 3.0
时间窗: 12 weeks
Pharmacokinetics
时间窗: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
次要结局
未报告次要终点