Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

University Hospital, Basel, Switzerland28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Polyuria-polydipsia Syndrome

Interventions

Macimorelin 0.5mg/kg body weightDRUG

oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin

Macimorelin 0.75mg/kg body weightDRUG

oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, Switzerland

Outcomes

Primary Outcomes

Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight

evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.5mg/kg body weight