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NCT03844217

Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

Datenbasis: WHO (Import vom 22.09.2019)
Geändert: 01.09.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Polyuria-polydipsia Syndrome

Interventions (Datenquelle: WHO)

Drug: Macimorelin 0.5mg/kg body weight;Drug: Macimorelin 0.75mg/kg body weight

Inclusion/Exclusion Criteria (Datenquelle: WHO)


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

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03844217

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03844217

Weitere Informationen zur Studie

Registrationsdatum der Studie

14.02.2019

Einschluss der ersten teilnehmenden Person

07.03.2019

Rekrutierungsstatus

Completed

Wissenschaftlicher Titel (Datenquelle: WHO)

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

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).

Phase (Datenquelle: WHO)

N/A

Primäre Endpunkte (Datenquelle: WHO)

Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight

Sekundäre Endpunkte (Datenquelle: WHO)

Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight;Change in Growth Hormone (GH) value (ng/mL);Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL);Change in free thyroxine (fT4) value (ng/dL);Change in Thyreotropin (TSH) value (mU/L);Change in Prolactin value (yg/L);Change in Cortisol value (ng/mL);Change in Adrenocorticotropin (ACTH) value ( pg/mL);Change in Luteotropin (LH) value (U/L);Change in Follicle-stimulating hormone value(FSH) (IU/mL)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Mirjam Christ-Crain, Prof. Dr. MD
Endocrinology, Diabetes and Metabolism, University Hospital Basel

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Mirjam Christ-Crain, Prof. Dr. MD
Endocrinology, Diabetes and Metabolism, University Hospital Basel

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

University Hospital, Basel, Switzerland

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2018-02205; me18ChristCrain4