Status:
COMPLETED
Effects of Substance P Antagonists on Adrenal Secretion
Lead Sponsor:
University Hospital, Rouen
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-30 years
Phase:
PHASE4
Brief Summary
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 cont...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- Male subjects;
- Age ranging 18 - 30 years old;
- Submitted to a social security regimen;
- Agreeing to the study \& Informed consent form signed;
- Body mass index (\[weight (kg)/height (m)\]²) \< 27;
- No treatment received 6 weeks before inclusion;
- No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG;
- 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
- No participation in a clinical trial 3 months before inclusion.
Exclusion
- Subject not agreeing to the study or impossible to follow-up;
- 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 ant/or metoclopramide;
- Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficit;
- Impaired lactose tolerance.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00977223
Start Date
June 1 2009
End Date
June 1 2010
Last Update
February 16 2012
Active Locations (1)
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1
Rouen Clinical research Centre (CIC 0204)
Rouen, Haute Normandie, France, 76031