The aim is to measure plasma aldosterone and cortisol concentrations in basal conditions and in response to different stimulation tests of the adrenal function
Conditions
Interventions
Trade Name: EMEND
Pharmaceutical Form: Capsule
INN or Proposed INN: APREPITANT
CAS Number: 170729-80-3
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 125-
Pharmace
Sponsors
CHU de Rouen
Eligibility
Sex/Gender
Male
Inclusion criteria
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) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Basal aldosterone alteration, aldosterone variation during metoclopramide and hypoglycaemia tests. Basal and stimulated alterations of renin, cortisol and ACTH during 3 different stimulatory tests (upright, metoclopramide and hypoglycaemia tests) ;Timepoint(s) of evaluation of this end point: Day 4, day 5 and day 7 of treatment | — |
Countries
France
Contacts
Public ContactTEILLARD
CHU de Rouen
Outcome results
None listed