NCT02040012Unknown1 期
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients With Type 2 Diabetes Mellitus
Alizé Pharma1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus.
研究概览
简要总结
Objectives:
Primary Objectives
- To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers.
- To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in overweight/obese volunteers.
- To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in patients with type 2 diabetes mellitus.
Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses.
Exploratory Objectives
• To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG)
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A: Healthy male volunteers, aged 18 to 50 years (inclusive) with a body mass index (BMI) of 20 to 28 kg/m2 (inclusive).
- •Part B: Female (of non-childbearing potential) and male overweight/obese volunteers, aged 18 to 65 years (inclusive) with a BMI of 28 to 38 kg/m2 (inclusive).
- •Part C: Female (of non-childbearing potential) and male patients with a confirmed diagnosis of type 2 diabetes mellitus for at least 3 months
排除标准
- •Part A: Females and male volunteers who smoke and/or use other nicotine products within 6 months of screening are excluded.
- •Part B: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) and any clinically significant abnormalities in physical examination, electrocardiogram (ECG), clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator.
- •Part C: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year), any clinically significant abnormalities other than those attributed to type 2 diabetes mellitus in physical examination, ECG, clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator, and estimated glomerular filtration rate <40 mL*min-1*1.73m-2 calculated by the Modification of Diet in Renal Disease formula.
研究组 & 干预措施
AZP-531
Active Comparator
subcut administration once or twice daily
干预措施: AZP-531 (Drug)
Mannitol
Placebo Comparator
subcut administration once or twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus.
时间窗: 1 to 14 days
次要结局
- To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses(1 to 14 days)
研究者
研究点 (1)
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