Clinical trial NCT02273427: Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers
Official title: Randomised 3-way Cross-over Phase I Study to Investigate the Effect of Different Food Compositions (Low Fat and High Fat Meal) on Bioavailability of BIIL 284 BS 75 mg Tablet in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: food effect, relative bioavailability, pharmacokinetics, safety and tolerability


Eligibility criteria: 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

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

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: up to 72 hours after drug administration
measure: Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity)
timeFrame: up to 72 hours after drug administration
Secondary outcomes:
measure: Time to Cmax (tmax)
timeFrame: up to 72 hours after drug administration
measure: Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz)
timeFrame: up to 72 hours after drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 72 hours after drug administration
measure: Total mean residence time (MRTtot)
timeFrame: up to 72 hours after drug administration
measure: Volume of distribution during terminal phase after oral administration (Vz/F)
timeFrame: up to 72 hours after drug administration
measure: Total clearance after oral administration (CLtot/F)
timeFrame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
Other outcomes:
Locations:
Study officials:
References: