Status:
COMPLETED
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.
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 \<= 45 years
- Broca \>= - 20 % and \<= + 20%
- Able to communicate well with the investigator and to comply with study requirements
- \> 10 elimination half lives present since last use of any investigational drug for that investigational drug
- Laboratory values within a clinically relevant reference range
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate, temperature, 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
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
- 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 (\< 1 months prior to administration or during trial)
- Smoker
- Inability to refrain from smoking on trial days
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) \< one week prior to administration of study drug
- Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
- Excessive physical activities (\< 5 days prior to administration or during the trial)
- Following specific laboratory findings: total white blood cell \>= 10 x 109/L, C-Reactive Protein \>= 4.5 mg/L, gamma-glutamyl-transferase \>= 25 U/L, aspartate transaminase \>= 16 U/L, alanine transaminase \>= 20 U/L any erythrocytes or \> 15 mg/dl protein on urine dipstick
- Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms, PR interval \> 240 ms, QRS interval \> 110 ms
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02209805
Start Date
January 1 2001
Last Update
August 6 2014
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