Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers

NCT02273414 | Completed Phase 1

• 1 other identifier: 543.4
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  up to 8 days after last drug administration

• Number of subjects with abnormal changes in laboratory parameters

  up to 8 days after last drug administration

• Number of subjects with clinically significant changes in vital signs

  Blood pressure, Pulse Rate, Respiratory Rate

  up to 8 days after last drug administration

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

  up to 8 days after last drug administration

Secondary Outcomes (11)

• 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

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 80 hours after drug administration

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 80 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

Study Arms (2)

BIIL 284 BS - rising dose

EXPERIMENTAL

Drug: BIIL 284 BS - rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 BS - rising dose DRUG

BIIL 284 BS - rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: July 1, 1999
• Primary Completion: September 1, 1999
• Last Updated: October 24, 2014

Record last verified: 2014-10