Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)

Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIIL 284 oral solution; Drug: BIIL 284 wetability improved formulation (WIF) tablets

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects as determined by results of screening
• Age ≥ 21 and ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%
• Signed written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

• Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
• Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Known 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 at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
• Participation in another study with an investigational drug within the last two months preceding this study
• Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day)
• Volunteer who is not able to refrain from smoking on study days
• Alcohol abuse (more than 60 g of alcohol per day)
• Drug abuse
• Excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation within the last 4 weeks (≥ 100 ml)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIIL 284 BS oral solution	Drug: BIIL 284 oral solution
Experimental: BIIL 284 BS WIF tablets	Drug: BIIL 284 wetability improved formulation (WIF) tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	up to 8 days after drug administration
Number of subjects with clinically relevant changes in vital signs	up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram	up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters	up to 8 days after drug administration
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)	up to 72 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Terminal half-life (t1/2)		up to 72 hours after drug administration
Total mean residence time (MRTtot)		up to 72 hours after drug administration
Changes in white blood cell count	determined by flow cytometer	up to 48 hours after drug administration
Changes in differential blood cell count	determined by flow cytometer	up to 48 hours after drug administration
Maximum plasma concentration (Cmax)		up to 72 hours after drug administration
Time to reach maximum plasma concentration (tmax)		up to 72 hours after drug administration
Area under the plasma concentration-time curve (AUC) for several time intervals		up to 72 hours after drug administration
Total clearance after oral administration (CLtot/f)		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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 543.1