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

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ClinicalTrials.gov Identifier: NCT02273427
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIL 284 BS Other: high fat meal Other: low fat meal Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2000
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BIIL 284 BS fasted Drug: BIIL 284 BS
Experimental: BIIL 284 BS with high fat meal Drug: BIIL 284 BS
Other: high fat meal
Experimental: BIIL 284 BS with low fat meal Drug: BIIL 284 BS
Other: low fat meal



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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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 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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273427    
Other Study ID Numbers: 543.5
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014