Asthma, Rhinitis, Allergic, Perennial
Conditions
Brief summary
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.
Interventions
DRUGBI 671800
In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
DRUGplacebo
Subjects will receive according to the dose group matching number of placebo tablets
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy 2. Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part. 3. Age \>= 20 and age =\< 50 4. Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2 5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
1. 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 2. Any evidence of a clinically relevant concomitant disease 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination | up to 4 days for SRD part and up to 15 days for MRD part |
| Vital signs; Blood Pressure(BP) | up to 4 days for SRD part and up to 15 days for MRD part |
| Vital signs; Pulse rate(PR) | up to 4 days for SRD part and up to 15 days for MRD part |
| 12-lead Electrocardiogram (ECG) | up to 4 days for SRD part and up to 15 days for MRD part |
| Clinical laboratory tests (Hematology) | up to 4 days for SRD part and up to 15 days for MRD part |
| Clinical laboratory tests (Clinical chemistry) | up to 4 days for SRD part and up to 15 days for MRD part |
| Clinical laboratory tests (Urinalysis) | up to 4 days for SRD part and up to 15 days for MRD part |
| Adverse events | up to 4 days for SRD part and up to 15 days for MRD part |
Secondary
| Measure | Time frame |
|---|---|
| SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957 | up to 4 days |
| SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800 | up to 4 days |
| SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800 | up to 4 days |
| MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| 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 | day1 Visit2, day1 Visit3 |
| 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 | day1 Visit2, day1 Visit3 |
| 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 | day1 Visit2, day1 Visit3 |
| MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957 | day1 Visit2, day1 Visit3 |
| MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800 | day1 Visit2, day1 Visit3 |
| MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800 | day1 Visit2, day1 Visit 3 |
| 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 | up to 12 days |
| MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957 | up to 12 days |
| 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 | up to 12 days |
| MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957 | up to 12 days |
| MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957 | up to 12 days |
| 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 | up to 12 days |
| SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957 | up to 4 days |
| MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957 | up to 12 days |
| MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957 | up to 12 days |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957 | up to 12 days |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800 | up to 12 days |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800 | up to 12 days |
| Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state | up to 12 days |
| Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state | up to 12 days |
| Linearity index (LI) of the analyte in plasma | up to 12 days |
| 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 | up to day 9 |
| 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 | up to day 9 |
| 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 | up to 12 days |
| SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957 | up to 4 days |
| 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 | up to 4 days |
| 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 | up to 4 days |
| 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 | up to 4 days |
| SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957 | up to 4 days |
| SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957 | up to 4 days |
| SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957 | up to 4 days |
Countries
South Korea
Outcome results
None listed