Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
研究概览
简要总结
This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
详细描述
Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No medication except hormonal contraception
排除标准
- •Body Mass Index (BMI) > 40kg/m2 or BMI < 18.5 kg/m2
- •participation in a trial with investigational drugs within 30 days
- •vigorous physical exercise within 24 hours before the study participation
- •Alcohol intake within 24 hours before study participation
- •pregnancy and breastfeeding
- •Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
- •a prolonged QT interval (QTc >500 ms) or concomitant treatment with drugs that prolong the QT/QTc.
- •Intention to become pregnant during the course of the study
- •Known allergy towards Macimorelin
研究组 & 干预措施
Macimorelin 0.5mg/kg body weight
Visit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin.
Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1.
Macimorelin 0.75mg/kg body weight
干预措施: Macimorelin 0.5mg/kg body weight (Drug)
Macimorelin 0.5mg/kg body weight
Visit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin.
Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1.
Macimorelin 0.75mg/kg body weight
干预措施: Macimorelin 0.75mg/kg body weight (Drug)
结局指标
主要结局
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
时间窗: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.5mg/kg body weight
次要结局
- Change in Cortisol value (ng/mL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Thyreotropin (TSH) value (mU/L)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in free thyroxine (fT4) value (ng/dL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Prolactin value (yg/L)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Adrenocorticotropin (ACTH) value ( pg/mL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Follicle-stimulating hormone value(FSH) (IU/mL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Growth Hormone (GH) value (ng/mL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)
- Change in Luteotropin (LH) value (U/L)(baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection)