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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03844217
Date of registration:	14/02/2019
Prospective Registration:	Yes
Primary sponsor:	University Hospital, Basel, Switzerland
Public title:	Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers Macicop
Scientific title:	Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
Date of first enrolment:	March 7, 2019
Target sample size:	28
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03844217
Study type:	Interventional
Study design:	Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Switzerland

Contacts

Name:	Mirjam Christ-Crain, Prof. Dr. MD
Address:
Telephone:
Email:
Affiliation:	Endocrinology, Diabetes and Metabolism, University Hospital Basel

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Polyuria-polydipsia Syndrome

Intervention(s)

Drug: Macimorelin 0.5mg/kg body weight

Drug: Macimorelin 0.75mg/kg body weight

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

2018-02205; me18ChristCrain4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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