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Completed

NCT Number: NCT02265302

Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

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

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BIIL 284 oral solution

Drug

BIIL 284 wetability improved formulation (WIF) tablets

Drug

Placebo

Drug

Primary outcomes

  1. Number of subjects with clinically relevant changes in vital signs

    Time frame: up to 8 days after drug administration

  2. Number of subjects with clinically relevant changes in electrocardiogram

    Time frame: up to 8 days after drug administration

  3. Number of subjects with clinically relevant changes in laboratory parameters

    Time frame: up to 8 days after drug administration

  4. Number of subjects with adverse events

    Time frame: up to 8 days after drug administration

  5. Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)

    Time frame: up to 72 hours after drug administration

Secondary outcomes

  1. Changes in white blood cell count

    Time frame: up to 48 hours after drug administration

    determined by flow cytometer

  2. Changes in differential blood cell count

    Time frame: up to 48 hours after drug administration

    determined by flow cytometer

  3. Maximum plasma concentration (Cmax)

    Time frame: up to 72 hours after drug administration

  4. Time to reach maximum plasma concentration (tmax)

    Time frame: up to 72 hours after drug administration

  5. Area under the plasma concentration-time curve (AUC) for several time intervals

    Time frame: up to 72 hours after drug administration

  6. Terminal half-life (t1/2)

    Time frame: up to 72 hours after drug administration

  7. Total mean residence time (MRTtot)

    Time frame: up to 72 hours after drug administration

  8. Total clearance after oral administration (CLtot/f)

    Time frame: up to 72 hours after drug administration

  9. Volume of distribution during terminal phase after oral administration (Vz/f)

    Time frame: up to 72 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
1998
Primary completion
1998
First posted
Oct 15, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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