Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 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
- 1
- 主要终点
- Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
研究概览
简要总结
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.
II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •Performance status - ECOG 0-2
- •RBC normal
- •WBC ≥ 3,000/mm^3
- •Platelet count normal
- •Hemoglobin normal
- •Hematocrit normal
- •ALT and AST normal
- •Bilirubin normal
- •Creatinine normal
- •No history of heart disease
- •EKG normal
- •No history of pancreatitis or obstruction of pancreatic ducts
- •No history of pancreatic cancer or pancreatic adenoma
- •Amylase normal
- •Lipase normal
- •Cholesterol normal
- •Triglycerides normal
- •Serum glucose ± 10% of normal
- •Within 15% of ideal body weight
- •No history of chronic medical condition
- •No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on average)
- •No history of amyloidosis
- •Non-smoker
- •Former smokers are eligible provided they have not smoked within the past 3 months
- •No history of medical condition that would influence gastrointestinal uptake of the study drug
- •No history of diabetes mellitus
- •No allergy or prior adverse reaction to soybeans
- •Not a vegetarian
- •No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- •No evidence of other life-threatening disease
- •No evidence of psychiatric problems
- •More than 12 months since prior chemotherapy
- •More than 1 month since prior experimental drugs
- •More than 3 days since prior consumption of alcoholic beverages
- •More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs
- •More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of > 2 per day
- •No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation
- •No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day
排除标准
- 未提供
研究组 & 干预措施
Arm I (Bowman-Birk inhibitor concentrate)
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.
干预措施: Bowman-Birk inhibitor concentrate (Drug)
Arm II (placebo)
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.
干预措施: placebo (Other)
结局指标
主要结局
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
时间窗: Up to 4 weeks
次要结局
- Pharmacokinetics measurements of BBI in the blood and urine(0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration)