Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

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.

Full Title of Study: “Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers – The Macicop-Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 16, 2019

Detailed 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.

Interventions

  • Drug: Macimorelin 0.5mg/kg body weight
    • oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
  • Drug: Macimorelin 0.75mg/kg body weight
    • oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight
    • Time Frame: 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 0.75mg/kg body weight
  • Change in Growth Hormone (GH) value (ng/mL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate GH values after the intake of of a single oral-dose Macimorelin
  • Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin
  • Change in free thyroxine (fT4) value (ng/dL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate fT4 values after the intake of of a single oral-dose Macimorelin
  • Change in Thyreotropin (TSH) value (mU/L)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate TSH values after the intake of of a single oral-dose Macimorelin
  • Change in Prolactin value (yg/L)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate Prolactin values after the intake of of a single oral-dose Macimorelin
  • Change in Cortisol value (ng/mL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate Cortisol values after the intake of of a single oral-dose Macimorelin
  • Change in Adrenocorticotropin (ACTH) value ( pg/mL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate ACTH values after the intake of of a single oral-dose Macimorelin
  • Change in Luteotropin (LH) value (U/L)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate LH values after the intake of of a single oral-dose Macimorelin
  • Change in Follicle-stimulating hormone value(FSH) (IU/mL)
    • Time Frame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
    • evaluate FSH values after the intake of of a single oral-dose Macimorelin

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mirjam Christ-Crain, Prof. Dr. MD, Principal Investigator, Endocrinology, Diabetes and Metabolism, University Hospital Basel

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