E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Possibe future indications: inflammatory conditions in general, auto-immune diseases |
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E.1.1.1 | Medical condition in easily understood language |
The investigated therapy could prove to be beneficial in a variety of conditions associated with inflammation, for example auto-immune diseases |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
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 objective of the study is to determine the effect of practicing the iceman’s concentration/meditation technique on the inflammatory response during human endotoxemia (lipopolysaccharide [LPS] administration in healthy volunteers). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are 1. To determine the effects of concentration/meditation on autonomic nervous system activity. 2. To determine the effects of the concentration/meditation technique on blood gas parameters. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥18 and ≤35 yrs
- Male
- Healthy
- Travel insurance (for travel to Poland) |
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E.4 | Principal exclusion criteria |
- Use of any medication
- Smoking
- Use of recreational drugs within 21 days prior to endotoxemia experiment day
- Use of caffeine or alcohol or within 1 day prior to endotoxemia experiment day
- Previous participation in a trial where LPS was administered
- Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day
- Participation in another clinical trial within 3 months prior to endotoxemia experiment day.
- History, signs, or symptoms of cardiovascular disease
- History of frequent vaso-vagal collapse or of orthostatic hypotension
- History of atrial or ventricular arrhythmia
- Hypertension (RR systolic >160 or RR diastolic >90)
- Hypotension (RR systolic <100 or RR diastolic <50)
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
- Renal impairment: plasma creatinine >120 µmol/L
- Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L
- History of asthma
- Obvious disease associated with immune deficiency.
- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study endpoint is the difference in circulating TNF-α following LPS administration between the concentration/meditation group and the control group. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0, 30, 60, 90, 120, 180, 240, 360, and 480 minutes after LPS administration. |
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E.5.2 | Secondary end point(s) |
- Other circulating cytokines (IL-6, IL-10 and IL1RA)
- Body temperature
- Hemodynamic parameters (heart rate, blood pressure)
- Leukocyte counts and differentiation
- Catecholamines (adrenaline and noradrenaline)
- Heart rate variability parameters as a measure of autonomic nervous system activity
- Blood gas parameters
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At various time-points or continuous between -30 and 480 minutes after LPS administration |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | 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 | Yes |
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 | 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 |
No concentration/meditation |
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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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |