E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy cardiovascular system |
Gezond cardiovasculair systeem |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy blood circulation |
Gezonde bloedsomloop |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
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 |
To explore the dose-response relationship between PaO2 and sublingual microcirculatory perfusion. |
Het onderzoeken van de dosis-respons relatie tussen PaO2 en sublinguale microcirculatoire perfusie. |
|
E.2.2 | Secondary objectives of the trial |
To explore the dose-response relationship between PaO2 and systemic hemodynamics |
Het onderzoeken van de dosis-respons relatie tussen PaO2 en systemische hemodynamiek |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy 18-55 years of age |
Gezond 18-55 jaar oud |
|
E.4 | Principal exclusion criteria |
- Active smoking - Diagnosed lung pathology (which requires medication or impedes exercise) - Diagnosed left-right shunt - Diagnosed cardiovascular disease |
- Actief roken - Gediagnosticeerde longafwijkingen (die sport beinvloeden of waarbij medicijnen nodig zijn) - Gediagnosticeerde links-rechts shunt - Gediagnosticeerde hart- of vaataandoening |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the change in perfused vessel density (PVD) of small vessels (<20 µm), as measured by sublingual sidestream darkfield imaging |
Verandering in perfused vessel density (PVD) van de sublinguale microcirculatie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 10 minutes of supplemental oxygen breathing |
Na 10 minuten zuurstof suppletie |
|
E.5.2 | Secondary end point(s) |
- Cardiac Output - Systemic Vascular Resistance - Heart Rate - Mean Arterial Pressure
|
- Hartminuutvolume - Systemische vaatweerstand - Hartritme - Gemiddelde arteriele druk |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 10 minutes of supplemental oxygen breathing |
Na 10 minuten zuurstof suppletie |
|
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 | Yes |
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) | 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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Increasing concentrations of oxygen to reach a predefined PaO2 |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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
|
LVLS |
Na het includeren van 15 gezonde vrijwilligers |
|
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 | |
E.8.9.1 | In the Member State concerned days | |