Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIIL 284 BS tablet C; Drug: BIIL 284 BS boli; Other: standard breakfast

• Registration Number: NCT02265640
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2000-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-15
• Last Update Submitted: 2014-10-15
• Study First Posted: 2014-10-16
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIIL 284 BS tablet C - fasted	BIIL 284 BS tablet C	-
BIIL 284 BS boli - fed	BIIL 284 BS boli	-
BIIL 284 BS boli - fasted	BIIL 284 BS boli	-
BIIL 284 BS boli - fed	standard breakfast	-
BIIL 284 BS tablet C - fed	standard breakfast	-
BIIL 284 BS tablet C - fed	BIIL 284 BS tablet C	-

Primary Outcome Measures

Name	Time	Method
Plasma levels of BIIL 315 ZW	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)	up to 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)	up to 72 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
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	blood pressure, pulse rate, ECG
Number of subjects with clinically significant findings in laboratory tests	up to 8 days after last drug administration