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NCT Number: NCT03844217

Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

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.

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Key information

Conditions

Polyuria-polydipsia Syndrome Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macimorelin 0.5mg/kg body weight

Drug

oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin

Macimorelin 0.75mg/kg body weight

Drug

oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: Macicop

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2019
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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