E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim is to measure plasma aldosterone and cortisol concentrations in basal conditions and in response to different stimulation tests of the adrenal function |
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E.1.1.1 | Medical condition in easily understood language |
aldosterone and cortisol concentrations in healthy volunteers |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
To determine the physiological conditions that involve the regulation of corticosteroid production by tachykinins. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) < 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma aldosterone levels during orthostatic test |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 4, day 5 and day 7 of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |