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CompletedNCT02265653Updated Oct 16, 2014

Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

A Phase 1 interventional study of BIIL 284 BS tablet C and BIIL 284 BS tablet D in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-16.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study summary

The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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 who have taken a drug with a long half-life (>= 24 hours) within 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 participated in another study with an investigational drug within the last two months preceding this study
  • Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    BIIL 284 BS tablet C

    Drug: BIIL 284 BS tablet C

  • Experimental
    BIIL 284 BS tablet D

    Drug: BIIL 284 BS tablet D

  • Active comparator
    BIIL 284 BS WIF tablet

    Drug: BIIL 284 BS WIF tablet

Interventions

  • DrugBIIL 284 BS tablet C
  • DrugBIIL 284 BS tablet D
  • DrugBIIL 284 BS WIF tablet
06

What researchers measure

Primary outcomes

  1. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 72 hours after drug administration

  2. Cmax (Maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

  4. t½ (Terminal half-life of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

  5. MRTtot (Total mean residence time)

    Time frame: up to 72 hours after drug administration

  6. Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  2. Number of subjects with clinically findings in vital functions

    blood pressure, pulse rate, ECG

    Time frame: up to 8 days after last drug administration

  3. Number of subjects with clinically findings in laboratory tests

    Time frame: up to 8 days after last drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02265653
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 16, 2014
Start date
Nov 1999
Primary completion
Dec 1999
Last update
Oct 16, 2014
View the source record on ClinicalTrials.gov ↗

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