NCT01096004已完成1 期
A Randomised, Single-blind, Placebo-controlled, Single-centre, Phase I Study in Abdominally Obese Healthy Volunteers to Evaluate Methods to Assess 11-βHSD1 Activity in Adipose Tissue and Related Downstream Biomarkers After Single and Repeated Oral Doses of AZD4017 for 10 Days
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
- 15
- 试验地点
- 1
- 主要终点
- To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
研究概览
简要总结
The primary purpose of this study is to investigate different methods to evaluate the effect of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese but otherwise healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written and dated informed consent
- •Have a body mass index (BMI) between 27 and 35 kg/m2
- •Waist circumference of >102 cm
排除标准
- •History of any clinical significant disease
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
研究组 & 干预措施
1
Experimental
干预措施: AZD4017 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
时间窗: A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.
次要结局
- Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables(The variables will be measure predose and the repeatedly during the following 10 days after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May ExperienceGastroesophageal Reflux DiseaseNCT01043185AstraZeneca27
已完成
2 期
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT00629239AstraZeneca65
已完成
1 期
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017HealthyNCT00791752AstraZeneca40
已完成
1 期
Single Ascending Dose Study (SAD) iv FormulationHealthyNCT00688831AstraZeneca36
已完成
1 期
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.HealthyNCT00799747AstraZeneca56