Clinical trial NCT02265302: Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 95
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of subjects with clinically relevant changes in vital signs
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in electrocardiogram
timeFrame: up to 8 days after drug administration
measure: Number of subjects with clinically relevant changes in laboratory parameters
timeFrame: up to 8 days after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after drug administration
measure: Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
timeFrame: up to 72 hours after drug administration
Secondary outcomes:
measure: Changes in white blood cell count
timeFrame: up to 48 hours after drug administration
measure: Changes in differential blood cell count
timeFrame: up to 48 hours after drug administration
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 72 hours after drug administration
measure: Time to reach maximum plasma concentration (tmax)
timeFrame: up to 72 hours after drug administration
measure: Area under the plasma concentration-time curve (AUC) for several time intervals
timeFrame: up to 72 hours after drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 72 hours after drug administration
measure: Total mean residence time (MRTtot)
timeFrame: up to 72 hours after drug administration
measure: Total clearance after oral administration (CLtot/f)
timeFrame: up to 72 hours after drug administration
measure: Volume of distribution during terminal phase after oral administration (Vz/f)
timeFrame: up to 72 hours after drug administration
Other outcomes:
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