A Double Blind, Placebo-controlled, Randomised, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GMC-252 in Healthy Male Subjects and Male Type 2 Diabetics
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of Participants with Serious and Non-Serious Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics.
The secondary objective is to explore the effect of multiple oral doses of GMC-252 on pharmacodynamic(PD) parameters in type 2 diabetics.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 3 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: GMC-252-L-Lysine Salt (Drug)
Cohort 1 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: GMC-252-L-Lysine Salt (Drug)
Cohort 1 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: Placebo (Other)
Cohort 2 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: GMC-252-L-Lysine Salt (Drug)
Cohort 2 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: Placebo (Other)
Cohort 3 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: Placebo (Other)
Cohort 4 (Part 2)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: GMC-252-L-Lysine Salt (Drug)
Cohort 4 (Part 2)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: 28 days plus 14 days post last dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
次要结局
- Area Under the Concentration-Time Curve(28 days plus 14 days post last dose)
- Maximal Concentration (Cmax)(28 days plus 14 days post last dose)
- Time to reach steady state(28 days plus 14 days post last dose)