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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ethanol

Criteria

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