E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glucagon-induced changes in heart rate, blood pressure, cardiac output. and metabolic effects |
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E.1.1.1 | Medical condition in easily understood language |
Changes in heart rate, blood pressure, heart function and metabolic effects due to glucagon.
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E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
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 observe the clinical effects of glucagon - compared to placebo - on hemodynamic parameters (blood pressure, heart rate and cardiac output) in healthy volunteers. |
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E.2.2 | Secondary objectives of the trial |
To observe the clinical effects of glucagon - compared to placebo on metabolic effects (on insulin, glucose, and amino acid levels) and register any potential adverse effects of glucagon |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible participants are males 18 to 40 years of age determined to be healthy by physical examination, medical history and routine laboratory tests (blood and urine) - i.e. normal levels of sodium, potassium, calcium, liver function, kidney function, hematological parameters, albumin, HbA1c, lipid levels. |
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E.4 | Principal exclusion criteria |
Routine laboratory tests outside normal ranges • Hypertension • Second and third degree atrioventricular conduction block • Resting Systolic blood pressure >140 or <100 mmHg • Resting heart rate < 45 beats per minute (bpm) • Sick sinus syndrome • Pheochromocytoma • Asthma • Chronic obstructive pulmonary disease • Abnormal body mass index • Claudicatio intermittens • Raynaud syndrome • Latex allergy • Any contraindications to glucagon
Any other previous or existing metabolic, heart or lung disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in heart rate compared between study days
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline and glucagon +5, +10, +15, +20, +30, +40, +50, +60, 90 minutter |
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E.5.2 | Secondary end point(s) |
changes is blood pressure, cardiac inotropy and metabolic effects |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline and glucagon +5, +10, +15, +20, +30, +40, +50, +60, 90 minutter |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
dose response relationship between glucagon levels and cardiovascular and metabolic effects |
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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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |