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

Boehringer Ingelheim0 sites35 target enrollmentJuly 1999

ConditionsHealthy

InterventionsBIIL 284 BS - rising dose Placebo

DrugsBIIL 284 BS - rising dose Placebo

Overview

Phase: Phase 1
Intervention: BIIL 284 BS - rising dose
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 35
Primary Endpoint: Number of subjects with adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 1999

End Date

September 1999

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

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

Arms & Interventions

BIIL 284 BS - rising dose

Intervention: BIIL 284 BS - rising dose

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with adverse events

Time Frame: up to 8 days after last drug administration

Number of subjects with abnormal changes in laboratory parameters

Time Frame: up to 8 days after last drug administration

Number of subjects with clinically significant changes in vital signs

Time Frame: up to 8 days after last drug administration

Blood pressure, Pulse Rate, Respiratory Rate

Number of subjects with clinically significant changes in 12-lead electrocardiogram

Time Frame: up to 8 days after last drug administration

Secondary Outcomes

tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 80 hours after drug administration)
Cmax (Maximum measured concentration of the analyte in plasma)(up to 80 hours after drug administration)
Changes in Leucotriene B4 (LTB4) induced Mac-1 expression(up to 24 hours after last treatment on day 9)
AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)(up to 24 hours after drug administration)
t½ (Terminal half-life of the analyte in plasma)(up to 80 hours after drug administration)
MRTtot (Total mean residence time)(up to 80 hours after drug administration)
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)(up to 80 hours after drug administration)
CLtot/F (Total clearance after oral administration)(up to 80 hours after drug administration)
Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)(up to 24 hours after drug administration)
AUCss (Area under the plasma concentration-time curve at steady state)(up to 80 hours after drug administration)
Cpre,ss (Predose concentration of the analyte in plasma at steady state)(up to 80 hours after drug administration)