Healthy Volunteers Clinical Trial
Official title:
Pilot Study of the Action of the Substance P Antagonist Aprepitant on Aldosterone and Cortisol Secretion in Healthy Volunteers.
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
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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