NCT01119352已完成1 期
A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects
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
- 45
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
研究概览
简要总结
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •suitable veins for cannulation or repeated venepuncture.
- •Have a body mass index (BMI) between 27 and 35 kg/m2
排除标准
- •Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening.
- •Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.
- •Smoking more than 7 cigarettes per week from time of consent
研究组 & 干预措施
1
Experimental
干预措施: AZD7687 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
时间窗: Before, during and after dosing.
次要结局
- Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters(Information will be collected from the time of day -2 throughout the study.)
- Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)(Information will be collected from the time of day -2 throughout the study.)
- Genetic: Blood sampling at one occasion during the study.(Once during study)
研究者
研究点 (1)
Loading locations...
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