Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects

Study Overview
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Brief Summary
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To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 Tablets in Otherwise Healthy Controlled Asthmatic Subjects (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)

Conditions
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Healthy, Asthma

Intervention / Treatment
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* Drug: Placebo to BI 1021958 qd
* Drug: BI 1021958 bid
* Drug: Placebo to BI 1021958 bid
* Drug: BI 1021958 qd


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1021958 qd<br>Multiple rising dose | Drug: BI 1021958 qd<br>* tablet<br>|
| Placebo Comparator: Placebo to BI 1021958 qd<br>Matching placebo as tablets | Drug: Placebo to BI 1021958 qd<br>* tablet<br>|
| Experimental: BI 1021958 bid<br>Multiple rising dose | Drug: BI 1021958 bid<br>* tablets<br>|
| Placebo Comparator: Placebo to BI 1021958 bid<br>Matching palcebo as tablet | Drug: Placebo to BI 1021958 bid<br>* tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with drug-related adverse events |  | up to day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 481:30 h | 
| 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 | 
| Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) |  | 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 |