A Clinical Trial to Evaluate the Effect of Nilotinib on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUGC
研究概览
简要总结
The aim of the study is to evaluate the effect of nilotinib on the pharmacokinetics and pharmacodynamics of metformin in healthy male adults
详细描述
Pharmacokinetics and pharmacodynamics of metformin without coadministration of nilotinib will be compared with those after administration of nilotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 19 and 50 years
- •Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
- •Subjects who agree with performing contraception during the study
- •Subjects who provides written informed consent
排除标准
- •Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
- •Subjects who have clinically significant allergic history or allergy to metformin, nilotinib, or other components of drug
- •Subjects with history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- •Subjects with hypokalemia or hypomagnesemia at screening
- •Subjects with QTcF > 450 or clinically significant findings on 12-lead ECG at screening
- •Subjects with fasting plasma glucose lower than 70 mg/dL or upper than 126 mg/dL at screening
- •Subjects who have history of gastrointestinal surgery
- •Subjects with creatinine clearance ≤ 60mL/min at screening
- •Subjects with AST or ALT ≥ 2-folds of upper normal limit
- •Subjects who reports less than 12 points on taste test at screening
- •Subjects who have administrated drugs that are known to cause significant drug-drug interaction with investigational drugs within 2 weeks prior to dosing
- •Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing, or received blood donation within 30 days prior to dosing
- •Subjects who participated in a previous clinical trial within 6 months prior to dosing
- •Subjects with a history of alcohol abuse
- •Subjects who are determined as unsuitable for clinical trial participation by investigator's decision
研究组 & 干预措施
Sequence A
Period 1: metformin; Period 2: metformin + nilotinib
干预措施: Metformin + Nilotinib (Drug)
Sequence A
Period 1: metformin; Period 2: metformin + nilotinib
干预措施: Metformin (Drug)
Sequence B
Period 1: metformin + nilotinib; Period 2: metformin
干预措施: Metformin (Drug)
Sequence B
Period 1: metformin + nilotinib; Period 2: metformin
干预措施: Metformin + Nilotinib (Drug)
结局指标
主要结局
AUGC
时间窗: 3 hours from 2 hour post-dose
Area under the concentration-time curve during oral glucose tolerance test
AUCinf
时间窗: 24 hours post-dose
Area under the concentration-time curve from time of administration extrapolated to infinity
Gmax
时间窗: 3 hours from 2 hour post-dose
maximum glucose level during oral glucose tolerance test
Cmax
时间窗: 24 hours post-dose
maximum concentration
次要结局
- Taste test(7 hour post-dose)
研究者
Hyewon Chung
Clinical Assistant Professor
Korea University Guro Hospital