E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We want to investigate the anti-inflammatory effects of local Solu-Dacortin application on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue in healthy volunteers. We use open-flow microperfusion to gain direct acces to interstitial fluid in adipose tissue in humans. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021959 |
E.1.2 | Term | Inflammation localized |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022078 |
E.1.2 | Term | Injection site inflammation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045995 |
E.1.2 | Term | Unspecified local infection of skin and subcutaneous tissue |
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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 |
To investigate the anti-inflammatory effects of local Solu-Dacortin application on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue (SAT) in healthy volunteers. |
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E.2.2 | Secondary objectives of the trial |
To compare the anti-inflammatory effects of local Solu-Dacortin application at two different times after catheter insertion on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue (SAT) in healthy volunteers.
To investigate the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) after insertion of a subcutaneous catheter during 25 hours.
To compare interstitial fluid cytokine, glucose and lactate concentrations with the serum concentrations at the corresponding time points.
To investigate the effect of Solu-Dacortin administration on glucose and lactate concentrations in ISF.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1)Signed informed consent obtained before any study related activities. (2)Age of patients in the range from 19 to 45 years. (3)BMI 20 - 29 kg/m²
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E.4 | Principal exclusion criteria |
(1)Any clinical signs of an acute inflammation as judged by the investigator. (2)Severe acute or chronic diseases (e.g. systemic lupus erythemadotes, rheumatoid arthritis). (3)Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. (4)Taking of any glucocorticoids, anti-inflammatory drugs, vasoactive substances or anticoagulation medication. (5)Diseases of the skin which could interfere with application of the catheters. (6)Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Time concentration profiles of interstitial fluid concentrations of cytokines (IL-1beta, IL- 6, IL-8, IL-10, TNF-alpha) with and without Solu-Dacortin administration.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
each subject serves as its own control |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |