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Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers (Macicop)

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ClinicalTrials.gov Identifier: NCT03844217
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Polyuria-polydipsia Syndrome Drug: Macimorelin 0.5mg/kg body weight Drug: Macimorelin 0.75mg/kg body weight Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Prospective, proof-of concept diagnostic study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
Actual Study Start Date : March 7, 2019
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine


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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844217


Locations
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Switzerland
University Hospital Basel Endocrinology, Diabetes and Metabolism
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Mirjam Christ-Crain, Prof. Dr. MD Endocrinology, Diabetes and Metabolism, University Hospital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03844217     History of Changes
Other Study ID Numbers: 2018-02205; me18ChristCrain4
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Copeptin
Macimorelin
Ghrelin receptor agonist
posterior pituitary gland
polyuria-polydipsia syndrome
hypothalamo-pituitary-adrenal axis
Additional relevant MeSH terms:
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Diabetes Insipidus
Polyuria
Polydipsia
Pathologic Processes
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Arginine Vasopressin
Tryptophan
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs