NCT00916604已完成1 期
A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
- •A body mass index (BMI) of 19 to 27 kg/m
- •Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
排除标准
- •Renal dysfunction GFR < 60 mL/min.
- •Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
- •History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
研究组 & 干预措施
A
Experimental
3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)
干预措施: AZD1656 (Drug)
B
Placebo Comparator
Placebo oral suspension given to 3 groups (2 on placebo in each group)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
时间窗: Blood samples taken repeatedly during 24 hours on study day sessions
次要结局
- Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).(Blood samples taken repeatedly during 24 hours on study day sessions)
- Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).(Blood samples taken repeatedly during 24 hours on study day sessions)
研究者
研究点 (1)
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