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

Phase 1

Completed

• Conditions: Healthy; Asthma
• Interventions: Drug: BI 1021958 qd; Drug: Placebo to BI 1021958 qd; Drug: BI 1021958 bid; Drug: Placebo to BI 1021958 bid

• Registration Number: NCT01629849
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Study Start: 2012-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1021958 qd	BI 1021958 qd	Multiple rising dose
Placebo to BI 1021958 qd	Placebo to BI 1021958 qd	Matching placebo as tablets
BI 1021958 bid	BI 1021958 bid	Multiple rising dose
Placebo to BI 1021958 bid	Placebo to BI 1021958 bid	Matching palcebo as tablet

Primary Outcome Measures

Name	Time	Method
Number of subjects with drug-related adverse events	up to day 22

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1310.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Gauting, Germany