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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:
ClinicalTrials.gov Identifier:
NCT01629849
First Posted: June 28, 2012
Last Update Posted: May 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects

Condition Intervention Phase
Healthy Asthma Drug: Placebo to BI 1021958 qd Drug: BI 1021958 bid Drug: Placebo to BI 1021958 bid Drug: BI 1021958 qd Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of subjects with drug-related adverse events [ Time Frame: up to day 22 ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 481:30 h ]
  • tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: up to 481:30 h ]
  • terminal rate constant in plasma [ Time Frame: up to 481:30 h ]
  • MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 481:30 h ]
  • 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 ]
  • tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 481:30 h ]
  • 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 ]
  • 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 ]
  • terminal rate constant in plasma at steady state [ Time Frame: up to 481:30 h ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 481:30 h ]
  • MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: up to 481:30 h ]
  • 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 ]
  • Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) [ Time Frame: up to 481:30 h ]
  • Cavg (average concentration) [ Time Frame: up to 481:30 h ]
  • PTF (peak trough fluctuation) [ Time Frame: up to 481:30 h ]

Enrollment: 84
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1021958 qd
Multiple rising dose
Drug: BI 1021958 qd
tablet
Placebo Comparator: Placebo to BI 1021958 qd
Matching placebo as tablets
Drug: Placebo to BI 1021958 qd
tablet
Experimental: BI 1021958 bid
Multiple rising dose
Drug: BI 1021958 bid
tablets
Placebo Comparator: Placebo to BI 1021958 bid
Matching palcebo as tablet
Drug: Placebo to BI 1021958 bid
tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629849


Locations
Germany
1310.2.1 Boehringer Ingelheim Investigational Site
Gauting, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01629849     History of Changes
Other Study ID Numbers: 1310.2
2012-000926-23 ( EudraCT Number: EudraCT )
First Submitted: June 21, 2012
First Posted: June 28, 2012
Last Update Posted: May 16, 2013
Last Verified: May 2013