Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers

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

food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BIIL 284 BS; Other: high fat meal; Other: low fat meal

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BIIL 284 BS fasted	Drug: BIIL 284 BS
Experimental: BIIL 284 BS with high fat meal	Drug: BIIL 284 BS; Other: high fat meal
Experimental: BIIL 284 BS with low fat meal	Drug: BIIL 284 BS; Other: low fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Terminal half-life (t1/2)		up to 72 hours after drug administration
Total mean residence time (MRTtot)		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
Number of subjects with adverse events		up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital functions	blood pressure, pulse rate, ECG	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (Actual): March 1, 2000

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 543.5