A Phase 4 interventional study of aprepitant/placebo in Healthy Volunteers, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-16.
Sponsored by University Hospital, Rouen · Phase 4 and Interventional
Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by sympathetic nervous system. This neurocrine regulation of corticosteroid secretion involves locally released neuropeptides. Among them, substance P is able to stimulate aldosterone and cortisol production via NK1 receptors.
The aim of the present study is to investigate the effects of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy volunteers. Aprepitant is a drug already available for the treatment of nausea induced by chemotherapy.
In the present phase IV trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by various stimuli, including upright posture, metoclopramide, and insulin-induced hypoglycaemia. All healthy volunteers will be given the two substances (aprepitant and placebo) in a random order during two one-week periods separated by a 14 day-wash-out.
This study should allow to determine the role of substance P in the control of corticosteroid production in normal man.
STUDY DESIGN
Phase IV, proof of concept, interventional, monocentric, randomised, double blind, cross-over study: The effects of a substance P antagonist (Emend) on corticosteroid secretion will be compared to those of a placebo.
STUDY OBJECTIVES
Main objective: to verify that adrenal corticosteroid secretion is actually controlled by substance P.
Secondary objective: to determine the physiological conditions that involve the control of adrenocortical function by tachykinins.
NUMBER OF SUBJECTS
20 healthy volunteers
ELIGIBILITY CRITERIA
(see below)
DURATION OF STUDY
Overall duration: 13 months Inclusion period: 12 months Follow up period (for 1 subject): 5 weeks Exclusion period: 1 month
ENDPOINTS
PRIMARY ENDPOINT: blood aldosterone variation during orthostatic test
SECONDARY ENDPOINTS
Basal aldosterone alteration Aldosterone variation during metoclopramide \& hypoglycaemia tests Basal and stimulated (3 different tests) alterations of renin, cortisol \& ACTH
REGULATORY AUTHORIZATIONS
Ethics committee authorization: dec 18th, 2008 Regulatory authorization: march 3rd, 2009
University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
No biological abnormality after the following biological testing:
Exclusion Criteria:
7 days treatment with study drug, order of periods (active treatment or placebo) being sorted out.
Drug: aprepitant/placebo
7 days treatment with study drug, order of periods (active treatment or placebo) being sorted out.
Drug: aprepitant/placebo
Aprepitant, 125 MG at day 1 then 80 MG day 2-7, once a day, per os, at 8 AM during breakfast
Also known as: DCI : Aprepitant, Brand name : Emend
Plasma aldosterone variation during orthostatic test
Time frame: Day 5 of treatment, at each period
Basal aldosterone alteration; Aldosterone variation during metoclopramide & hypoglycaemia tests; Basal and stimulated (3 different tests) alterations of renin, cortisol & ACTH
Time frame: Day 4, 5 and 7 of treatment, at each period
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen