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

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ClinicalTrials.gov Identifier: NCT02273414
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIL 284 BS - rising dose Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 1999
Actual Primary Completion Date : September 1999

Arm Intervention/treatment
Experimental: BIIL 284 BS - rising dose Drug: BIIL 284 BS - rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 8 days after last drug administration ]
  2. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 8 days after last drug administration ]
  3. 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

  4. Number of subjects with clinically significant changes in 12-lead electrocardiogram [ Time Frame: up to 8 days after last drug administration ]

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


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273414    
Other Study ID Numbers: 543.4
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014