Status:
COMPLETED
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
19-54 years
Phase:
PHASE1
Brief Summary
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level...
Eligibility Criteria
Inclusion
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age \> 18 and \< 55 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, immunological or hormonal (including thyroid) disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease of the central nervous system (such as epilepsy) or psychiatric 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) (\<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the result of the trial (\<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (\<= 2 month prior to administration or during the trial)
- Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
- Inability to refrain from smoking during the period of the study
- Known alcohol (\>60 g/day) or drug abuse
- Blood donation (\<=1 month prior to administration)
- Excessive physical activities (\<5 days prior to administration)
- Any laboratory value outside the normal range of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT02229838
Start Date
July 1 1999
Last Update
September 1 2014
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