Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.
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 \<= 45 years
- Broca \>= -20% and \<= +20%
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) 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 ot 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 (=2 months prior to administration or during trial)
- Smoker (\> 10 cigarettes of \> 3 cigars of \> 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Blood donation \> 400 ml (=1 month prior to administration of during the trial)
- Excessive physical activities (= 5 days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count \>= 10 x 10\*\*9/L, C-reactive protein \>= 4.5 mg/L, any haemoglobin or \> 15 mg/dl protein on urine dipstick
- History of any familial bleeding disorder
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02208856
Start Date
September 1 1999
Last Update
August 5 2014
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