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Completed

NCT Number: NCT01629849

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

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

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Key information

Conditions

Healthy Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1310.2.1 Boehringer Ingelheim Investigational Site

Gauting, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects ofn non child-bearing potential

Exclusion criteria

  • Any relevant deviation from healthy conditions except mild controlled asthma

Treatment and study plan

Placebo to BI 1021958 qd

Drug

tablet

BI 1021958 bid

Drug

tablets

Placebo to BI 1021958 bid

Drug

tablets

BI 1021958 qd

Drug

tablet

Primary outcomes

  1. Number of subjects with drug-related adverse events

    Time frame: up to day 22

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 481:30 h

  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma)

    Time frame: up to 481:30 h

  3. 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

  4. 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

  5. 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

  6. 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

  7. terminal rate constant in plasma

    Time frame: up to 481:30 h

  8. MRTpo (mean residence time of the analyte in the body after oral administration)

    Time frame: up to 481:30 h

  9. 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

  10. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)

    Time frame: up to 481:30 h

  11. 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

  12. 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

  13. terminal rate constant in plasma at steady state

    Time frame: up to 481:30 h

  14. t1/2,ss (terminal half-life of the analyte in plasma at steady state)

    Time frame: up to 481:30 h

  15. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)

    Time frame: up to 481:30 h

  16. 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

  17. Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)

    Time frame: up to 481:30 h

  18. Cavg (average concentration)

    Time frame: up to 481:30 h

  19. PTF (peak trough fluctuation)

    Time frame: up to 481:30 h

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2012
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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