A Randomized, Single-Blind, Placebo-Controlled, Single-Center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Fasting After Single Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients
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
- To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.
详细描述
This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be of non-childbearing potential.
- •Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
- •Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin
排除标准
- •Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
- •Participation in another clinical study during the last 30 days prior to enrollment
- •Significant cardiovascular event within the last 6 months prior to enrollment
研究组 & 干预措施
6 - 8 cohorts
2 patients in each cohort will receive placebo
干预措施: AZD5658 (Drug)
6 - 8 cohorts
2 patients in each cohort will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
时间窗: AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3
次要结局
- To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.(Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose)
- Pharmacodynamics (plasma glucose and serum insulin)(Plasma glucose and serum insulin determined on Day -1 through Day 4)
- Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.