A Randomized, Open-Label, Drug-Drug Interaction Study To Evaluate The Effect Of Ketoconazole Or Rifampicin On The Pharmacokinetic Characteristics And Safety Of Lc15-0444 In Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
详细描述
This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on the PK characteristic and safety of LC15-0444.
Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks(-28 d ~ -2 d) before the first drug administration(1 d). Eligible subjects will be randomized to one of study treatment groups.
According to the characteristics of anti-diabetic drugs, it is expected to be administered with other drugs in many patients. Therefore, Drug-Drug Interaction with CYP3A4 inducer and inhibitor should be identified in this trial.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Is a healthy male between 20 and 50 years old
- •Has BMI result between 19 and 26 kg/m2 at screening; and a total body weight over 55 kg. BMI(kg/m2) = body weight(kg)/{height(m)}
- •Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Agrees to use an adequate means of contraception during clinical trials
排除标准
- •Subjects with evidence or history of clinically significant hepatic, renal, digestive, neurologic, pulmonary, musculoskeletal, endocrine, hematological, cardiovascular or psychiatric disease
- •Subjects with evidence or history of gastrointestinal disease or surgery possibly affecting drug absorption.
- •Subjects with history of hypersensitivities or clinically significant adverse events caused by DPPIV inhibitors, ketoconazole, rifampicin, and other drugs
- •Subjects who have donated a unit of blood within 60 days or blood components within 30 days before the first administration of the investigational product.
- •Subjects who consume excessive alcohol or caffeine; who excessively smoke
研究组 & 干预措施
Study A
干预措施: Ketoconazole (Drug)
Study B
干预措施: rifampicin (Drug)
结局指标
主要结局
Cmax
时间窗: Until Day 18 or 20
AUC(last)
时间窗: Until Day 18 or 20
AUC(0-24hr)
时间窗: Until Day 18 or 20
Tmax
时间窗: Until Day 18 or 20
t(1/2beta)
时间窗: Until Day 18 or 20
(6-b-hydrocortisol)/(cortisol) ratio
时间窗: Until Day 20
次要结局
未报告次要终点