Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-07

Study Completion Date

2019-07-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polyuria-polydipsia Syndrome

Study Design

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Intervention Model

SEQUENTIAL

Prospective, proof-of concept diagnostic study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Macimorelin 0.5mg/kg body weight

Intervention Type DRUG

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

Macimorelin 0.75mg/kg body weight

Intervention Type DRUG

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

Interventions

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Macimorelin 0.5mg/kg body weight

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

Intervention Type DRUG

Macimorelin 0.75mg/kg body weight

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes