Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Bile acid metabolism effect
研究概览
简要总结
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
排除标准
- •Cardiovascular disease
- •Cerebrovascular disease (e.g. stroke, prior aneurysm)
- •Pulmonary disease (e.g. pulmonary hypertension, COPD)
- •Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
- •Renal disease (by Chronic kidney disease criteria)
- •Active inflammatory bowel syndrome
- •Pregnancy
- •Any chronic medication use
- •Steroid treatment for the last six months or hormone replacement therapy
- •Coagulopathy
- •Musculoskeletal or neurologic disease
- •Know allergy against any of the studied substances
- •Inclusion in any other concurrent medical research study
研究组 & 干预措施
Full group
Evolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily.
After continued atorvastatin, evolocumab 140 mg is added subcutaneously.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Bile acid metabolism effect
时间窗: 32 hours
Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time.
Cholesterol metabolism effect
时间窗: 32 hours
Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time.
次要结局
未报告次要终点