E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We wish to determine, whether PET-scans with Rubidium-82 can be used to determine renal blood flow |
Vi undersøger, om PET-scanning med rubidium-82 som radioaktiv isotop kan anvendes til bestemmelse af det renale blod flow |
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E.1.1.1 | Medical condition in easily understood language |
We wish to determine, whether PET-scans with Rubidium-82 as radioactive isotope can be used to determine blood flow in the kidneys. |
Vi undersøger, om PET-scanning med rubidium-82 som radioaktivt sporstof kan anvendes til bestemmelse af det blodgennemstrømningen i nyrerne |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 develop a new and reliable method to determine renal blood flow based on Rubidium-82 and PET-technology using a 1-tissue compartment model |
At udvikle en ny pålidelig metode til bestemmelse af RBF baseret på Rubidium-82 og PET-teknologi med anvendelse af en 1-tissue compartment model |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-40 years, BMI 18,5-30 kg/m2, women must use contraception |
Alder 18-40 år, BMI 18,5-30 kg/m2, kvinder skal anvende sikker antikonception |
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E.4 | Principal exclusion criteria |
Medical treatment in the last 2 weeks except for contraception, pregnancy or nursing, consumption of more than 14 units of alcohol for men and more than 7 for women per week, tobacco smoking, neoplasm, clinically significant heart, lung, liver, kidney, metanolic or neurologic disorders, clinically significant findings in blood samples, urine sample or ECG, office blood pressure > 140/90mmHg, substance abuse |
Medicinsk behandling (inkl. håndkøbsmedicin) inden for de sidste to uger fraset hormonel antikonception, graviditet eller amning, alkoholoverforbrug > 7 genstande/ uge for kvinder og > 14 genstande/ uge for mænd, tobaksrygning, Cancer, Anamnestiske eller kliniske tegn på betydende hjerte-, lunge-, lever-, nyre-, stofskiftesygdomme eller neurologiske lidelser, Klinisk betydende afvigelser ved screeningsblodprøver, urinstix eller EKG, Konsultationsblodtryk > 140/90 mmHg, stofmisbrug
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E.5 End points |
E.5.1 | Primary end point(s) |
Renal blood flow |
Blodgennemstrømningen i nyrerne |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial when all subjects have completed the day of examination |
I slutningen af forsøget, når alle forsøgspersonerne har gennemført undersøgelsesdagen. |
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E.5.2 | Secondary end point(s) |
Intra-assay variationcoefficient |
Intra-assay variationskoefficienten |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial when all subjects have completed the day of examination |
I slutningen af forsøget, når alle forsøgspersonerne har gennemført undersøgelsesdagen. |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Developement of a new method |
Metodeudvikling |
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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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |