E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Phase I healthy volunteer study |
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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 assess the free unbound concentration of budesonide in Serum, Muscle tissue, and Subcutaneous adipose tissue |
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E.2.2 | Secondary objectives of the trial |
· To assess total concentrations (bound and unbound) of budesonide in serum · To assess metabolites of budesonide in serum (if feasible) · To assess safety and tolerability |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· Subject has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure · White (Caucasian origin) healthy male/female subjects, aged between 18 and 45 years (inclusive) · Normal body weight as evidenced by a Body Mass Index (BMI) between > or = 18 and < or = 28kg/m², and a body weight > 50 kg · Safe contraception in females of childbearing potential during the entire study, which means the use of effective birth-control methods such as hormonal contraceptives for at least 2 months prior to start of screening, double barrier method (condoms and diaphragms) or intra-uterine devices, which were thought to be medically acceptable forms of birth control |
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E.4 | Principal exclusion criteria |
Safety concerns: · History or current evidence of allergies or idiosyncrasy to drugs or food, if considered relevant at the discretion of the investigator · History of allergic reactions to any active or inactive ingredient of the trial medication · History or current evidence of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease within the last 2 years, if considered relevant at the discretion of the investigator · Impairment of blood coagulation · History of malignancy within the past 5 years · Electrocardiogram (ECG) abnormalities of relevance (assessment by investigator, e.g. QTc according to Bazett: males and females > 450 ms, PQ > or = 220 ms) · Relevant (assessment by investigator) abnormalities in clinical chemical, hematological or any other laboratory variables · Chronic or clinically relevant acute infections (assessment by investigator) · Proneness to orthostatic dysregulation, fainting, or blackouts · Positive results in any of the virology tests for HIV-Ab1 or HIV-Ab2, HCV-Ab, HBsAg. · Drug screen positive or not performed · Abuse of alcohol (>2 drinks/day defined according to USDA Dietary Guidelines 2005) or drugs · Pregnant or lactating females · ß-HCG pregnancy test (female subjects) positive or not performed
Lack of suitability for the trial: · Treatment with any known CYP3A4-isoenzyme inducing / inhibiting agents (barbiturates, phenothiazines, cimetidine, ketoconazole etc.) and eating Brussels sprout or broccoli and eating grapefruits or star fruits, drinking of star- or grapefruit juice within two weeks prior to the study · Use of any medication (incl. herbal and over-the-counter (OTC) medication) within two weeks before trial drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives) · Vegetarian diet or other peculiar dietary habits which would preclude the subject’s acceptance of standardized meals · Surgery of the gastrointestinal tract which may interfere with drug absorption · Participation in drug trials within the last 30 days before start of the study (last day of intake of medication – first day of medication in the following study) · Smoking of more than 5 cigarettes daily · Anticipated donation of spermatocytes or oocytes for medically assisted reproduction techniques (ART) within 2 months after the last dose of the present trial · Blood donation within the last 30 days before start of the study
Administrative reasons: · Lack of ability or willingness to give informed consent · Anticipated non-availability for study visits/procedures. · Anticipated lack of willingness or inability to cooperate adequately · Vulnerable subjects (e.g. persons kept in detention) · Anticipated lack of ability or willingness to apply safe contraception (female subjects) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Free unbound concentrations of budesonide as obtained by microdialysis in serum, muscle tissue and subcutaneous adipose tissue |
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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 | Information not present in EudraCT |
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 | 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) | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |