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

CHU de Rouen0 个研究点目标入组 20 人开始时间: 2009年2月6日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•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

•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.

发起方

CHU de Rouen