Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

Study Overview
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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.

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.

Official Title
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Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study

Conditions
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Polyuria-polydipsia Syndrome

Intervention / Treatment
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* Drug: Macimorelin 0.5mg/kg body weight
* Drug: Macimorelin 0.75mg/kg body weight


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, proof-of concept diagnostic study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macimorelin 0.5mg/kg body weight<br>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 | Drug: Macimorelin 0.5mg/kg body weight<br>* oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin<br>Drug: Macimorelin 0.75mg/kg body weight<br>* oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight | evaluate copeptin values after the intake of of a single oral-dose 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 Growth Hormone (GH) value (ng/mL) | evaluate GH values after the intake of of a single oral-dose Macimorelin | 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) | evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin | 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) | evaluate fT4 values after the intake of of a single oral-dose Macimorelin | 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) | evaluate TSH values after the intake of of a single oral-dose Macimorelin | 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) | evaluate Prolactin values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | 
| Change in Cortisol value (ng/mL) | evaluate Cortisol values after the intake of of a single oral-dose Macimorelin | 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) | evaluate ACTH values after the intake of of a single oral-dose Macimorelin | 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) | evaluate LH values after the intake of of a single oral-dose Macimorelin | 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) | evaluate FSH values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis