Asthma, Healthy
Conditions
Brief summary
To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects
Interventions
DRUGPlacebo to BI 1021958 qd
tablet
DRUGBI 1021958 bid
tablets
DRUGPlacebo to BI 1021958 bid
tablets
DRUGBI 1021958 qd
tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1\. Healthy male and female subjects ofn non child-bearing potential
Exclusion criteria
1\. Any relevant deviation from healthy conditions except mild controlled asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with drug-related adverse events | up to day 22 |
Secondary
| Measure | Time frame |
|---|---|
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) | up to 481:30 h |
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) | up to 481:30 h |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval) | up to 481:30 h |
| AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 481:30 h |
| Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered | up to 481:30 h |
| terminal rate constant in plasma | up to 481:30 h |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 481:30 h |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
| tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) | up to 481:30 h |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 481:30 h |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
| terminal rate constant in plasma at steady state | up to 481:30 h |
| t1/2,ss (terminal half-life of the analyte in plasma at steady state) | up to 481:30 h |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) | up to 481:30 h |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) | up to 481:30 h |
| Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) | up to 481:30 h |
| Cavg (average concentration) | up to 481:30 h |
| PTF (peak trough fluctuation) | up to 481:30 h |
| Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
Countries
Germany
Outcome results
None listed