Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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 subje...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02184338
Start Date
August 1 2004
Last Update
July 14 2014
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