E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
The response over time on daytime alertness and performance will be assessed following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa, which equals an airliner cabin altitude of about 8,000 feet. |
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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 |
- All subjects must be normal healthy (non-smoking) males ages 18-40 of any race. - Negative urine screen for drugs with a high potential for abuse. - Subjects must be free of any clinically significant disease which would interfere with the study evaluations or study treatments. - Subjects must have an ECG -QTc time within normal limits - Body Mass Index must be between 19 and 30 kg/m2 - Subjects must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements. - Adequate adaptation towards the differences in cabin pressure
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E.4 | Principal exclusion criteria |
- Subjects who have clinically significant abnormal physical findings or vital signs which could interfere with the objectives of the study. This includes subjects who have any history or symptoms of chronic illness, history of psychotic disorders, drug addiction or abuse of drugs or alcohol, or impaired mentation which could interfere with the completion of the study. - Subjects requiring any CNS medication, or medication with sedative effects. - Subjects who have taken macrolide Antibiotics, antifungals, cimetidine, ranitidine within 7 days before the study - Use of (non) prescription medications within the last 14 days, with the exception of aspirin and paracetamol up to 48 hours prior to the start of the study - alcohol consumption of more than 21 units per week; caffeine consumption of more than 6 cups per day; regular drinking of citric or grapefruit juice; treatment by atropine or atropine-like drugs - Subjects with a history of allergies to more than two classes of medication or who are allergic to or cannot tolerate antihistamines. - Subjects who have had an upper respiratory tract or sinus infection or who have had a viral upper respiratory infection within 7 days prior to Screening. - Subjects with active seasonal and/or perennial allergic rhinitis. - Subjects with urticaria - The investigational study staff involved with this study. - Subjects who have taken a sedative/hypnotic, antihistaminic or anticholinergic drugs during the three weeks prior to entering the first treatment phase. - Subjects who have consumed alcoholic beverages within the last 24 hours prior to the start of the study or during the treatment study days.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Vigilance &Tracking Test (VigTrack): root mean square of tracking error, percentage omissions, number of false reactions; 2) Multi-Attribute Task Battery (MAT): a) Monitoring performance: number of false reactions, number of omissions, mean response time; b) Tracking performance: root mean square of tracking error; c) Resource management: mean absolute deviation from target; 3) Stanford Sleepiness Scale (SSS): SSS-scores. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluations will be done at +1, +2, +3, +5, and +6 hours following each drug administration period. |
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E.5.2 | Secondary end point(s) |
Peripheral Hemoglobin-Oxygen Saturation (SaO2). Adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
SaO2 the first day on each treatment period. Adverse events during al treatment periods |
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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 | 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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 |