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

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

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 Overview

• Status: Completed
• Conditions: Polyuria-polydipsia Syndrome
• Intervention / Treatment: Drug: Macimorelin 0.5mg/kg body weight; Drug: Macimorelin 0.75mg/kg body weight

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel Endocrinology, Diabetes and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, Prof. Dr. MD, Endocrinology, Diabetes and Metabolism, University Hospital Basel

Publications and helpful links

General Publications

• Urwyler SA, Lustenberger S, Drummond JR, Soares BS, Vogt DR, Ammer N, Yuen KCJ, Ribeiro-Oliveira A, Christ-Crain M. Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. Pituitary. 2021 Aug;24(4):555-563. doi: 10.1007/s11102-021-01132-9. Epub 2021 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Copeptin; Macimorelin; Ghrelin receptor agonist; posterior pituitary gland; polyuria-polydipsia syndrome; hypothalamo-pituitary-adrenal axis
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Pituitary Diseases; Polyuria; Diabetes Insipidus; Polydipsia; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: 2018-02205; me18ChristCrain4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No