NCT02265640CompletedPhase 1
Randomised 4-way Cross-over Phase I Study to Investigate the Relative Bioavailability of BIIL 284 BS 75 mg Boli in Comparison to Tablet C in Fasted Condition and After Ingestion of a Standardised Meal in Healthy Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16
- Primary Endpoint
- Plasma levels of BIIL 315 ZW
Study Overview
Brief Summary
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All participants are healthy males
- •Age range from 21 to 50 years
- •Broca-Index: within +- 20% of normal weight
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 with psychiatric 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 a drug with a long half-life (> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment 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 study with an investigational drug (>= tow months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 60g/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
Arms & Interventions
BIIL 284 BS boli - fasted
Experimental
Intervention: BIIL 284 BS boli (Drug)
BIIL 284 BS boli - fed
Experimental
Intervention: BIIL 284 BS boli (Drug)
BIIL 284 BS boli - fed
Experimental
Intervention: standard breakfast (Other)
BIIL 284 BS tablet C - fasted
Active Comparator
Intervention: BIIL 284 BS tablet C (Drug)
BIIL 284 BS tablet C - fed
Active Comparator
Intervention: BIIL 284 BS tablet C (Drug)
BIIL 284 BS tablet C - fed
Active Comparator
Intervention: standard breakfast (Other)
Outcomes
Primary Outcomes
Plasma levels of BIIL 315 ZW
Time Frame: up to 72 hours after drug administration
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time Frame: up to 72 hours after drug administration
Secondary Outcomes
- tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 72 hours after drug administration)
- t½ (Terminal half-life of the analyte in plasma)(up to 72 hours after drug administration)
- MRTtot (Total mean residence time)(up to 72 hours after drug administration)
- Vz/F (Apparent volume of distribution of the analyte during the terminal phase)(up to 72 hours after drug administration)
- CLtot/F (Total clearance after oral administration)(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)
- Number of subjects with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
Investigators
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