Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (Macicop)

University Hospital Basel

Status: Completed

Conditions: Polyuria-polydipsia Syndrome

Treatments: Drug: Macimorelin 0.5mg/kg body weight; Drug: Macimorelin 0.75mg/kg body weight

Study type: Interventional

Funder types: Other

Identifiers

NCT03844217

2018-02205 me18ChristCrain4;

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No medication except hormonal contraception

Exclusion criteria

• 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

Trial design

28 participants in 1 patient group

Macimorelin 0.5mg/kg body weight

Experimental group

Description:

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

Treatment:

Drug: Macimorelin 0.75mg/kg body weight

Drug: Macimorelin 0.5mg/kg body weight