NCT01221545已完成1 期
A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (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
- Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
研究概览
简要总结
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures.
- •Male, T2DM patients aged 20-60 years
- •Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
- •Patients should not have been treated with glitazones within 6 months prior to enrollment
- •Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
排除标准
- •History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
- •Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- •Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1
研究组 & 干预措施
A - AZD1656
Experimental
AZD1656
干预措施: AZD1656 (Drug)
B - Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
时间窗: From screening until Follow up
次要结局
- Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656(From pre-dose Day 1 to 48 hours after dose)
- Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656(Insuline secretion from Day -1 to 2.)
研究者
研究点 (1)
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