A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
详细描述
EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.
This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.
In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.
This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers between the ages of 18 and 55 years inclusive.
- •In good health.
- •Female subjects must be surgically sterilized or postmenopausal.
- •Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
- •Non-smoker.
- •Negative drug and alcohol screens.
排除标准
- •Abnormal ECG
- •Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
- •Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- •Previous treatment with EGT
- •History of drug abuse.
- •Febrile illness within 5 days prior to the first dose of study medication.
研究组 & 干预措施
EGT0001474
Ascending doses of EGT0001474
干预措施: EGT0001474 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Tmax
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups
AUC 0-t
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.
t1/2
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results.t 1/2 - apparent terminal half life
AUC 0 -24
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Terminal Rate Constant.
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data
CL/F
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetics results. Apparent oral clearance
VZ/F
时间窗: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Pharmacokinetic results. Apparent volume of distribution
次要结局
未报告次要终点