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OpenTrials
Completed

NCT Number: NCT02273427

Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers

food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Completed

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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

  • All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
  • All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study

Exclusion criteria

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • 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 drugs 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
  • Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
  • Excessive physical activities (within the last week before the study)
  • Any laboratory value outside the reference range of clinical relevance

Treatment and study plan

BIIL 284 BS

Drug

high fat meal

Other

low fat meal

Other

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: up to 72 hours after drug administration

  2. Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity)

    Time frame: up to 72 hours after drug administration

Secondary outcomes

  1. Time to Cmax (tmax)

    Time frame: up to 72 hours after drug administration

  2. Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz)

    Time frame: up to 72 hours after drug administration

  3. Terminal half-life (t1/2)

    Time frame: up to 72 hours after drug administration

  4. Total mean residence time (MRTtot)

    Time frame: up to 72 hours after drug administration

  5. Volume of distribution during terminal phase after oral administration (Vz/F)

    Time frame: up to 72 hours after drug administration

  6. Total clearance after oral administration (CLtot/F)

    Time frame: up to 72 hours after drug administration

  7. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  8. Number of subjects with clinically significant findings in vital functions

    Time frame: up to 8 days after last drug administration

    blood pressure, pulse rate, ECG

  9. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 8 days after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Randomised 3-way Cross-over Phase I Study to Investigate the Effect of Different Food Compositions (Low Fat and High Fat Meal) on Bioavailability of BIIL 284 BS 75 mg Tablet in Healthy Male Volunteers

Important dates

Study start
2000
Primary completion
2000
First posted
Oct 24, 2014
Registry last updated
Oct 24, 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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