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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01629849
First received: June 21, 2012
Last updated: May 15, 2013
Last verified: May 2013

June 21, 2012
May 15, 2013
July 2012
December 2012   (final data collection date for primary outcome measure)
Number of subjects with drug-related adverse events [ Time Frame: up to day 22 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01629849 on ClinicalTrials.gov Archive Site
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • terminal rate constant in plasma [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • terminal rate constant in plasma at steady state [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • Cavg (average concentration) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
  • PTF (peak trough fluctuation) [ Time Frame: up to 481:30 h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects
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)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Healthy
  • Asthma
  • Drug: Placebo to BI 1021958 qd
    tablet
  • Drug: BI 1021958 bid
    tablets
  • Drug: Placebo to BI 1021958 bid
    tablets
  • Drug: BI 1021958 qd
    tablet
  • Experimental: BI 1021958 qd
    Multiple rising dose
    Intervention: Drug: BI 1021958 qd
  • Placebo Comparator: Placebo to BI 1021958 qd
    Matching placebo as tablets
    Intervention: Drug: Placebo to BI 1021958 qd
  • Experimental: BI 1021958 bid
    Multiple rising dose
    Intervention: Drug: BI 1021958 bid
  • Placebo Comparator: Placebo to BI 1021958 bid
    Matching palcebo as tablet
    Intervention: Drug: Placebo to BI 1021958 bid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
December 2012
December 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01629849
1310.2, 2012-000926-23
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP