- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844217
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (Macicop)
August 7, 2019 updated by: University Hospital, Basel, Switzerland
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Basel, Switzerland, 4031
- University Hospital Basel Endocrinology, Diabetes and Metabolism
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
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 |
oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
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
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
|
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
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
|
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)
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
|
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)
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
|
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)
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
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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)
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
|
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)
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
|
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)
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
|
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)
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
|
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)
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
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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)
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
|
baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mirjam Christ-Crain, Prof. Dr. MD, Endocrinology, Diabetes and Metabolism, University Hospital Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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