Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

Polyuria-polydipsia Syndrome Clinical Trial

— Macicop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844217
• Other study ID #: 2018-02205; me18ChristCrain4
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: July 16, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Polydipsia
• Polyuria
• Polyuria-polydipsia Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel Endocrinology, Diabetes and Metabolism	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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