E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The catabolic effects induced by long-term glucocorticoid treatment. |
|
E.1.1.1 | Medical condition in easily understood language |
The tissue depleting effects induced by long-term glucocorticoid treatment. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
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 main purpose of the tríal is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid. More specifically we are interested in the molecular mechanisms by which glucocorticoid inhibits growth. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of glucocorticoid treatment on the activity of the circulating Insulin-like Growth Factor (IGF) system in healthy adults and intracellular in vitro and in vivo studies of IGF-I receptor phosphorylation and intracellular signaling in muscle and tissue biopsies. IGF levels in in serum vs. interstitiel fluid. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed and dated informed consent
Healthy subjects
Sex: male
Age 20-30 years
BMI 19-26 kg/m2
normal HbA1c |
|
E.4 | Principal exclusion criteria |
Suspected or known allergy to the trial drug or similar medications.
Known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhytmia.
Daily drug intake (excluding OCT preparations).
Known or previous mental illness.
Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study.
participation in a larger X-ray examinations in trial period |
|
E.5 End points |
E.5.1 | Primary end point(s) |
GH and IGF-profiles of subjects before and after prednisolon-treatment. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolon treatment. |
|
E.5.2 | Secondary end point(s) |
insulin sensitivity and intracellulair signaling of IGF-I under the influence/abscence of prednisolon |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
hyperinsulinemic euglycemic clamp and tissue biopsi on day 5. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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
|
The end of the trial is the last visit of the last patient.
First patient, first visit approximately 01/01/2013
last patient, last visit approximately 01/01/2014 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |