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

Primary Purpose

Polyuria-polydipsia Syndrome

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Macimorelin 0.5mg/kg body weight
Macimorelin 0.75mg/kg body weight
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyuria-polydipsia Syndrome focused on measuring Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel Endocrinology, Diabetes and Metabolism

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Macimorelin 0.5mg/kg body weight

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in Growth Hormone (GH) value (ng/mL)
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)
evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin
Change in free thyroxine (fT4) value (ng/dL)
evaluate fT4 values after the intake of of a single oral-dose Macimorelin
Change in Thyreotropin (TSH) value (mU/L)
evaluate TSH values after the intake of of a single oral-dose Macimorelin
Change in Prolactin value (yg/L)
evaluate Prolactin values after the intake of of a single oral-dose Macimorelin
Change in Cortisol value (ng/mL)
evaluate Cortisol values after the intake of of a single oral-dose Macimorelin
Change in Adrenocorticotropin (ACTH) value ( pg/mL)
evaluate ACTH values after the intake of of a single oral-dose Macimorelin
Change in Luteotropin (LH) value (U/L)
evaluate LH values after the intake of of a single oral-dose Macimorelin
Change in Follicle-stimulating hormone value(FSH) (IU/mL)
evaluate FSH values after the intake of of a single oral-dose Macimorelin

Full Information

First Posted
February 14, 2019
Last Updated
August 7, 2019
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03844217
Brief Title
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
Acronym
Macicop
Official Title
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyuria-polydipsia Syndrome
Keywords
Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective, proof-of concept diagnostic study
Masking
None (Open Label)
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macimorelin 0.5mg/kg body weight
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Macimorelin 0.5mg/kg body weight
Intervention Description
oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
Intervention Type
Drug
Intervention Name(s)
Macimorelin 0.75mg/kg body weight
Intervention Description
oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
Primary Outcome Measure Information:
Title
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
Description
evaluate copeptin values after the intake of of a single oral-dose 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
Secondary Outcome Measure Information:
Title
Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight
Description
evaluate copeptin values after the intake of of a single oral-dose 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
Title
Change in Growth Hormone (GH) value (ng/mL)
Description
evaluate GH values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)
Description
evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in free thyroxine (fT4) value (ng/dL)
Description
evaluate fT4 values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Thyreotropin (TSH) value (mU/L)
Description
evaluate TSH values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Prolactin value (yg/L)
Description
evaluate Prolactin values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Cortisol value (ng/mL)
Description
evaluate Cortisol values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Adrenocorticotropin (ACTH) value ( pg/mL)
Description
evaluate ACTH values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Luteotropin (LH) value (U/L)
Description
evaluate LH values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Title
Change in Follicle-stimulating hormone value(FSH) (IU/mL)
Description
evaluate FSH values after the intake of of a single oral-dose Macimorelin
Time Frame
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof. Dr. MD
Organizational Affiliation
Endocrinology, Diabetes and Metabolism, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel Endocrinology, Diabetes and Metabolism
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33615399
Citation
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.
Results Reference
derived

Learn more about this trial

Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

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