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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BIIL 284 oral solution; Drug: BIIL 284 wetability improved formulation (WIF) tablets

• Registration Number: NCT02265302
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 1998-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 95

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BIIL 284 BS oral solution	BIIL 284 oral solution	-
BIIL 284 BS WIF tablets	BIIL 284 wetability improved formulation (WIF) tablets	-

Primary Outcome Measures

Name	Time	Method
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)	up to 72 hours 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
Number of subjects with adverse events	up to 8 days after drug administration

Secondary Outcome Measures

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