Clinical trial NCT01629849: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with drug-related adverse events
timeFrame: up to day 22
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 481:30 h
measure: tmax (time from dosing to maximum measured concentration of the analyte in plasma)
timeFrame: up to 481:30 h
measure: 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)
timeFrame: up to 481:30 h
measure: 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)
timeFrame: up to 481:30 h
measure: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 481:30 h
measure: Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered
timeFrame: up to 481:30 h
measure: terminal rate constant in plasma
timeFrame: up to 481:30 h
measure: MRTpo (mean residence time of the analyte in the body after oral administration)
timeFrame: up to 481:30 h
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
timeFrame: up to 481:30 h
measure: tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
timeFrame: up to 481:30 h
measure: Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)
timeFrame: up to 481:30 h
measure: AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
timeFrame: up to 481:30 h
measure: terminal rate constant in plasma at steady state
timeFrame: up to 481:30 h
measure: t1/2,ss (terminal half-life of the analyte in plasma at steady state)
timeFrame: up to 481:30 h
measure: MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
timeFrame: up to 481:30 h
measure: CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
timeFrame: up to 481:30 h
measure: Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
timeFrame: up to 481:30 h
measure: Cavg (average concentration)
timeFrame: up to 481:30 h
measure: PTF (peak trough fluctuation)
timeFrame: up to 481:30 h
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: 1310.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: