E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with cystic fibrosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011762 |
E.1.2 | Term | Cystic fibrosis |
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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 endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoint of the trial is to determine if the frequency of adverse reactions and side-effects of oral voriconazole in adult patients with cystic fibrosis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Confirmed cystic fibrosis according to the US Cystic Fibrosis Foundation guidelines •Male or female subjects aged between 18 and 40 years; •Hospitalised subject requiring routine intravenous antibiotic treatment; •Written informed consent has been obtained; •Pancreatic insufficiency as determined by a faecal elastase of <100μg g-1
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E.4 | Principal exclusion criteria |
•Known history or suspicion of alcohol or drug abuse; •Pregnancy or breast-feeding female; •Female subject of childbearing potential without adequate contraception; •Participation in an investigational drug trial in the 30 days prior to selection; •Known hypersensitivity to voriconazole or other azole (Fluconazole, Itraconazole, Ketoconazole, Ravuconazole, Posaconazole) antifungal agents; •Known history of severe drug allergy or hypersensitivity; •Has received systemic voriconazole within two weeks before study entry; •Is receiving treatment with drugs that are contraindicated (See Concomitant therapy); •Weight of less than 40kg •Has liver disease defined as liver enzymes > twice the upper normal limit or bilirubin > 50mmol/l at trial entry; |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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The end of the trial will be 30 days after the last visit of the last subject. |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |