Clinical trial NCT02273414: Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (9 Days Dosing) of BIIL 284 BS (Doses: 25 mg, 150 mg, 250 mg as WIF Tablets) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 35
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: The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor


Eligibility criteria: Inclusion Criteria:

* All participants are healthy males
* Age range from 21 to 50 years
* Broca-Index: within +- 20% of their normal weight
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers with eosinophilia \> 7 %
* Volunteers who have taken 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 enrollment in the study
* Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke
* Volunteers who drink more than 60g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
* Volunteers who have donated blood within the last 4 weeks (\>= 100 mL)

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant changes in 12-lead electrocardiogram
timeFrame: up to 8 days after last drug administration
Secondary outcomes:
measure: AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
timeFrame: up to 24 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 80 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 80 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 80 hours after drug administration
measure: MRTtot (Total mean residence time)
timeFrame: up to 80 hours after drug administration
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
timeFrame: up to 80 hours after drug administration
measure: CLtot/F (Total clearance after oral administration)
timeFrame: up to 80 hours after drug administration
measure: Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)
timeFrame: up to 24 hours after drug administration
measure: AUCss (Area under the plasma concentration-time curve at steady state)
timeFrame: up to 80 hours after drug administration
measure: Cpre,ss (Predose concentration of the analyte in plasma at steady state)
timeFrame: up to 80 hours after drug administration
measure: Changes in Leucotriene B4 (LTB4) induced Mac-1 expression
timeFrame: up to 24 hours after last treatment on day 9
Other outcomes:
Locations:
Study officials:
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