(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
研究概览
简要总结
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
详细描述
This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy or pre-diabetic based on medical history
- •Male or female
- •Must be 21 to 75 years of age (inclusive)
- •Able to give informed consent to the procedures
- •If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
- •If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
- •Medication use stable for 4 weeks
- •Body Mass Index (BMI) > 27 kg/m^2
- •Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes
排除标准
- •Type 2 diabetes
- •Pregnancy
- •Younger than 21 or older than 75 years of age
- •Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory
- •Recent MI or stroke (within 6 months of screening)
- •Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
- •Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
- •Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism
研究组 & 干预措施
10 mg (+)-epicatechin
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
干预措施: (+)-Epicatechin (Drug)
30 mg (+)-epicatechin
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
干预措施: (+)-Epicatechin (Drug)
100 mg (+)-epicatechin
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
干预措施: (+)-Epicatechin (Drug)
结局指标
主要结局
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
时间窗: Baseline and 24 hours
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
次要结局
- Change From Baseline in Major Safety Endpoints(Baseline and 24 hours)
- Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)(Baseline and 24 hours)
- Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)(Baseline and 24 hours)
- Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)(Baseline and 24 hours)
研究者
Robert R. Henry, MD
Chief, Section of Diabetes, Endocrinology and Metabolism
Veterans Medical Research Foundation