Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS (5, 25, 100, 250, 500, and 800 mg) as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects. Placebo Controlled and Blinded at Each Dose Level

Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in healthy male subjects

Inclusion Criteria:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 50 years
• BMI >18.5 and <29.9 kg/m2 (Body Mass Index)

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (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) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial (< 10 days prior to study drug administration or expected during the trial)
• Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
• Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
• Excessive physical activities (within 5 days prior to administration or during the trial)
• Clinically relevant laboratory abnormalities
• Any electrocardiogram value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms or QT >500 ms
• Known hypersensitivity to the drug or its excipients
• Inability to comply with dietary regimen of study centre
• Inability to comply with investigator's instructions