Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics 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 safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
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%
Exclusion
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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) within 1 month prior to administration or during the trial)
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Blood donation \> 400 ml within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10\*\*9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or \> 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02211157
Start Date
March 1 2000
Last Update
August 8 2014
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