E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers |
Gezonde vrijwilligers |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers |
Gezonde vrijwilligers |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024981 |
E.1.2 | Term | Lower urinary tract infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The primary objective of this study is to measure the fosfomycin concentrations in urine after a single, oral dose of 3 grams. |
Het doel van deze studie is om de urineconcentraties te bepalen van fosfomycine na een eenmalige, orale dosis van 3 gram. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to design a model which describes the pharmacokinetics and the pharmacodynamics of fosfomycin. This model will offer the possibility to predict the urine concentrations of fosfomycin and to optimise dosing regimens. Also, to find out for how long the concentrations will be 'high' and to find out which parameters (for example, age and/or renal function) influence the concentrations of fosfomycin in urine. |
Het secondaire doel van deze studie is om een model te ontwikkelen die de farmacokinetiek en de farmacodynamiek van fosfomycine beschrijft. Met dit model kunnen urineconcentraties van fosfomycine in toekomstige patiënten worden voorspelt en kunnen individuele dosisregims worden ontworpen. Daarnaast kan hiermee worden onderzocht welke parameters (bijvoorbeeld leeftijd en nierfunctie) invloed hebben op deze fosfomycine concentraties. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- female - age of al least 18 years old |
- vrouw - leeftijd van minimaal 18 jaar oud |
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E.4 | Principal exclusion criteria |
- male - menstruation during the study week - any kind of infectious disease which is treated during the study week - use of metoclopramide - preganancy - lactation |
- man - menstrueren tijdens de studieweek - infectie ziekte die behandeld wordt tijdens de studieweek - co-medicatie: metoclopramide - zwangerschap - lactatie |
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E.5 End points |
E.5.1 | Primary end point(s) |
fosfomycin concentrations in urine |
fosfomycine concentraties in urine |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Fosfomycin concentrations will be evaluated after completion of the study. Volunteers should collect urine samples during 7 days after administration of 3 grams fosfomycin. Afterwards, they hand in the samples and the investigators will measure the fosfomycin concentrations in the urine samples. |
Fosfomycine concentraties zullen pas na het voltooien van de studie worden bepaald. De vrijwilligers verzamelen gedurende 7 dagen na het innemen van de fosfomycine hun urine. Daarna leveren ze de monsters in bij de onderzoekers waarna de fosfomycineconcentraties in het lab van de ziekenhuisapotheek zullen worden bepaald. |
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E.5.2 | Secondary end point(s) |
- Percentage of time above the minimal inhibitory concentration of the most common uropathogens (%T>MIC) - Estimation of the renal function based on creatinine in urine and in blood - Fluid intake during the sample collection week
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- Percentage tijd boven de 'minimale inhibitory concentration' (MIC) van de meest voorkomende uropathogenen (%T>MIC) - Schatting van de nierfunctie op basis van serumcreatinine en creatinine in de 24-uurs urine - Vochtinname gedurende de studieweek |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- %T>MIC will be evaluated after the fosfomycine concentrations were measured in the lab. - The renal function, based on a blood-sample, will be calculated directly after sample collection. The renal function, based on the 24-hours urine, will be calculated after the volunteers handed-in their samples. - fluid intake will be calculated after receiving this information from the volunteers. |
- %T>MIC zal worden bepaald nadat de fosfomycine concentraties in de urinemonsters zijn bepaald. - Nierfunctie op basis van het bloedsmonster, zal direct worden berekend na afname van dit monster. - Nierfunctie op basis van de 24-uurs urine zal worden berekend na bepalen van creatinine concentraties in deze monsters. - Vochtinname zal worden berekend na het inleven van de informatie hierover door de vrijwilligers. |
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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 | 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) | 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 | 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.8.2.4 | 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
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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 |