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Completed

NCT Number: NCT01216384

Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers

The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1268.15.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
  • Age >= 20 and age =< 50
  • Body Mass Index (BMI) >=18.5 and BMI =< 25 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

  • Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
  • Any evidence of a clinically relevant concomitant disease
  • Intake of drugs with long half life (>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Treatment and study plan

BI 671800

Drug

In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.

Placebo

Drug

Subjects will receive according to the dose group matching number of placebo tablets

Primary outcomes

  1. Physical examination

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  2. Vital signs; Blood Pressure(BP)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  3. Vital signs; Pulse rate(PR)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  4. 12-lead Electrocardiogram (ECG)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  5. Clinical laboratory tests (Hematology)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  6. Clinical laboratory tests (Clinical chemistry)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  7. Clinical laboratory tests (Urinalysis)

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

  8. Adverse events

    Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Secondary outcomes

  1. SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957

    Time frame: up to 4 days

  2. SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957

    Time frame: up to 4 days

  3. SRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957

    Time frame: up to 4 days

  4. SRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) BI 671800 and BI 600957

    Time frame: up to 4 days

  5. SRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 671800 and BI 600957

    Time frame: up to 4 days

  6. SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957

    Time frame: up to 4 days

  7. SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957

    Time frame: up to 4 days

  8. SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957

    Time frame: up to 4 days

  9. SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957

    Time frame: up to 4 days

  10. SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800

    Time frame: up to 4 days

  11. SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800

    Time frame: up to 4 days

  12. MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  13. MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  14. MRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  15. MRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  16. MRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) , BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  17. MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  18. MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  19. MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  20. MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957

    Time frame: day1 Visit2, day1 Visit3

  21. MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800

    Time frame: day1 Visit2, day1 Visit3

  22. MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800

    Time frame: day1 Visit2, day1 Visit 3

  23. MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, BI 671800 and BI 600957

    Time frame: up to 12 days

  24. MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957

    Time frame: up to 12 days

  25. MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957

    Time frame: up to 12 days

  26. MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957

    Time frame: up to 12 days

  27. MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957

    Time frame: up to 12 days

  28. MRD Part,AUCt1-t2,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time interval t1 to t2) BI 671800 and BI 600957

    Time frame: up to 12 days

  29. MRD Part,AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957

    Time frame: up to 12 days

  30. MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957

    Time frame: up to 12 days

  31. MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957

    Time frame: up to 12 days

  32. MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957

    Time frame: up to 12 days

  33. CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800

    Time frame: up to 12 days

  34. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800

    Time frame: up to 12 days

  35. Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state

    Time frame: up to 12 days

  36. Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state

    Time frame: up to 12 days

  37. Linearity index (LI) of the analyte in plasma

    Time frame: up to 12 days

  38. AUEC0-24,N absolute inhibition of eosinophil shape change: area under the absolute inhibition of shape change-time curve after the Nth dose of BI 671800 HEA

    Time frame: up to day 9

  39. AUEC0-24,N percent inhibition of eosinophil shape change: area under the percent inhibition of shape change - time curve after the Nth dose of BI 671800

    Time frame: up to day 9

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers

Important dates

Study start
2010
Primary completion
2010
First posted
Oct 7, 2010
Registry last updated
Nov 19, 2013

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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