Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation 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
- Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay
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 healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
详细描述
OBJECTIVES:
I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants.
II. Determine the appropriate dose range and doses to be used in a subsequent phase I multiple-dose BBIC study that will be based upon the data gathered from this phase I single-dose study.
III. Characterize the pharmacokinetics of single-dose BBIC.
OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC). Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo or BBIC.
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 male participant recruited from the Philadelphia, Pennsylvania metropolitan area
- •ECOG performance status 0-2
- •WBC ≥ 3,000/uL
- •Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
- •Platelet count normal
- •Hemoglobin normal
- •Hematocrit normal
- •RBC normal
- •Creatinine normal
- •Bilirubin normal
- •ALT and AST normal
- •Amylase and lipase normal
- •Glucose normal
- •Cholesterol normal
- •Triglycerides normal
- •Non-smoker
- •Former smokers are eligible provided they have not smoked within the past 3 months
- •Within 15% of ideal body weight based on standard weight tables
- •No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day
- •No prior allergy or adverse reaction to soybeans
- •No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- •No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis
- •No history of heart disease
- •EKG normal (normal variants allowed)
- •No evidence of psychiatric problems
- •No history of excessive alcohol consumption (i.e., an average of > 2 alcoholic beverages per day)
- •No alcohol consumption within the past 3 days
- •No history of any medical condition that could influence gastrointestinal uptake of the drug
- •No history of chronic medical condition
- •No evidence of another life-threatening disease
- •More than 12 months since prior chemotherapy
- •More than 1 month since prior experimental drugs
- •More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs)
- •More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of > 2 per day
排除标准
- 未提供
研究组 & 干预措施
Arm I
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
干预措施: Bowman-Birk inhibitor concentrate (Drug)
Arm I
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
干预措施: placebo (Other)
Arm I
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
干预措施: pharmacological study (Other)
Arm I
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay
时间窗: Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration
Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.
Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria
时间窗: Up to 48 hours
次要结局
未报告次要终点