NCT03844217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

February 14, 2019

Last Update Submit

August 7, 2019

Conditions

Polyuria-polydipsia Syndrome

Keywords

CopeptinMacimorelinGhrelin receptor agonistposterior pituitary glandpolyuria-polydipsia syndromehypothalamo-pituitary-adrenal axis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in Copeptin value (pmol/l), after intake of 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

  • Change in Growth Hormone (GH) value (ng/mL)

    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)

    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)

    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)

    baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection

  • +5 more secondary outcomes

Study Arms (1)

Macimorelin 0.5mg/kg body weight

EXPERIMENTAL

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 weightDrug: Macimorelin 0.75mg/kg body weight

Interventions

Macimorelin 0.5mg/kg body weightDRUG

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

Macimorelin 0.5mg/kg body weight
Macimorelin 0.75mg/kg body weightDRUG

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

Macimorelin 0.5mg/kg body weight

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No medication except hormonal contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Urwyler SA, Lustenberger S, Drummond JR, Soares BS, Vogt DR, Ammer N, Yuen KCJ, Ribeiro-Oliveira A, Christ-Crain M. Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. Pituitary. 2021 Aug;24(4):555-563. doi: 10.1007/s11102-021-01132-9. Epub 2021 Feb 22.

    PMID: 33615399DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

macimorelinWeights and Measures

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Mirjam Christ-Crain, Prof. Dr. MD

    Endocrinology, Diabetes and Metabolism, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Prospective, proof-of concept diagnostic study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

March 7, 2019

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

CH(1)