Status:
COMPLETED
Effect of Single Oral Dose BIRB 796 BS on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
- Age ≥18 and ≤ 35 years
- Broca ≥- 20 % and ≤ + 20%
- Able to communicate well with the investigator and to comply with study requirements
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections within 14 days of enrolment
- 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 administration or during the trial)
- Participation in another trial with an investigational drug (\< 3 months prior to administration or 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 (\< 2 month prior to administration or during the trial)
- Excessive physical activities (\< 24 hours prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- History of any familial bleeding disorder
- Weight \> 150 kg
- Prior confirmed or suspected receipt of a monoclonal antibody
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02211170
Start Date
February 1 2000
Last Update
August 7 2014
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