Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BIIL 284 BSOther: low fat mealOther: high fat meal
- Registration Number
- NCT02273427
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
food effect, relative bioavailability, pharmacokinetics, safety and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
- All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
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Exclusion Criteria
- 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
- 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
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= two months prior to administration or during the 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 (>= 100 ml within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIIL 284 BS fasted BIIL 284 BS - BIIL 284 BS with low fat meal low fat meal - BIIL 284 BS with high fat meal BIIL 284 BS - BIIL 284 BS with high fat meal high fat meal - BIIL 284 BS with low fat meal BIIL 284 BS -
- Primary Outcome Measures
Name Time Method Maximum concentration (Cmax) up to 72 hours after drug administration Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity) up to 72 hours after drug administration
- Secondary Outcome Measures
Name Time Method Total mean residence time (MRTtot) up to 72 hours after drug administration Time to Cmax (tmax) up to 72 hours after drug administration Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz) up to 72 hours after drug administration Volume of distribution during terminal phase after oral administration (Vz/F) up to 72 hours after drug administration Total clearance after oral administration (CLtot/F) up to 72 hours after drug administration Terminal half-life (t1/2) up to 72 hours after drug administration Number of subjects with adverse events up to 8 days after last drug administration Number of subjects with clinically significant findings in vital functions up to 8 days after last drug administration blood pressure, pulse rate, ECG
Number of subjects with clinically significant findings in laboratory tests up to 8 days after last drug administration