Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

Inclusion criteria

• age ≥ 18 and ≤55 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2
• healthy male subjects as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG at the screening visit
• signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• non-smoker (a subject is considered to be a non-smoker if he has never smoked or has stopped smoking ≥ 6 months before the screening visit)
• agree not to take any prescription medications or non-prescription drugs (including herbal preparations and vitamins) without approval by the investigator and not to receive vaccinations during the course of the study
• agree not to eat oranges, grapefruits, broccoli, Brussels sprouts, or char grilled meats and not to drink grapefruit juice during the course of the study
• agree not to drink alcoholic beverages during the course of the study
• agree not to drink or eat caffeine and theobromine containing beverages and foods during the course of the study

Exclusion criteria

• any finding of the medical examination (including Blood Pressure, Pulse Rate, and ECG) deviating from normal and of clinical relevance
• gastrointestinal, hepatic, renal, respiratory (e.g. asthma), cardiovascular, metabolic, immunologic, haematological, oncological, or hormonal disorders
• any surgical or medical condition that could interfere with the administration of the study drug or interpretation of the study results
• diseases of the Central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
• relevant history of orthostatic hypotension, fainting spells, or blackouts
• chronic or relevant acute infections
• history of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
• immunisation during the 2 weeks prior to the screening visit
• known intolerance to benzodiazepines
• known intolerance to the active and/or inactive ingredients in caffeine, warfarin, vitamin K1, omeprazole, or dextromethorphan
• known acute angle-closure glaucoma
• elevated prothrombin time as determined by Prothrombin time (INR) > 1.3
• intake of drugs with a long half-life (greater than 24 hrs) (less than one month prior to administration or during the trial)
• use of any drugs which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
• use of chewing tobacco or nicotine replacement devices within 6 months before the screening visit
• participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• alcohol abuse (more than 60 g of ethanol per day)
• blood donation or loss greater than 100 mL (less than one month prior to administration or expected during the trial)
• clinically relevant laboratory abnormalities