Pilot study of the effect of a substance P antagonist, aprepitant, on aldosterone and cortisol secretions in healthy volunteers

Phase 1

• Conditions: The aim is to measure plasma aldosterone and cortisol concentrations in basal conditions and in response to different stimulation tests of the adrenal function; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2008-003367-40-FR
• Lead Sponsor: CHU de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-06
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

o Male subjects;
o Age ranging 18 - 30 years old;
o Submitted to a social security regimen;
o Agreeing to the study & Informed consent form signed;
o Body mass index (weight (kg)/height (m)²) < 27;
o No treatment received 6 weeks before inclusion;
o No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG;
o No biological abnormality after the following biological testing:
- Hematology: white & red blood cells & platelets count, haemoglobin, hematocrit
- Blood biochemistry: sodium, potassium, chloride, bicarbonate, creatinine, urea
- Urinary biochemistry (24 h collection): cortisol, aldosterone
- Serologies: HIV, HBV, HCV
o No participation in a clinical trial 3 months before inclusion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject not agreeing to the study or impossible to follow-up; the persons in detention by judicial or administrative decision, patients hospitalized without consent, individuals admitted to a health or social facility for purposes other than research and legally protected adults or not in a position to express their consent.
• Known history of significant medical or surgical pathology, notably endocrine;
• Renal or hepatic insufficiency;
• Nephrotic syndrome;
• Edematous syndrome;
• Hypertension or postural hypotension;
• Cardiac rhythm or conduction pathologies;
• Cardiac insufficiency;
• Epilepsy;
• Significant psychiatric disorder;
• Known history of severe allergy, hypersensitivity to aprepitant and/or metoclopramide;
• Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficit;
• Impaired lactose tolerance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to use the NK1 receptor antagonist aprepitant as a pharmacological tool to determine the physiological role of the regulation of adrenocortical secretions by the sympathetic system via SP. The influence of the compound on plasma aldosterone and cortisol concentrations will be evaluated in basal conditions and after stimulation.<br>This pilot proof-of-concept study will allow us verifying that corticosteroid secretions are actually controlled in vivo by a neural stimulatory tone via SP<br><br>;Secondary Objective: To determine the physiological conditions that involve the regulation of corticosteroid production by tachykinins.;Primary end point(s): Plasma aldosterone levels during orthostatic test;Timepoint(s) of evaluation of this end point: Day 4 of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Basal aldosterone alteration, aldosterone variation during metoclopramide and hypoglycaemia tests. <br>Basal and stimulated alterations of renin, cortisol and ACTH during 3 different stimulatory tests (upright, metoclopramide and hypoglycaemia tests)<br>;Timepoint(s) of evaluation of this end point: Day 4, day 5 and day 7 of treatment