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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:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01629849
First received: June 21, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629849

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

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01629849     History of Changes
Other Study ID Numbers: 1310.2, 2012-000926-23
Study First Received: June 21, 2012
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013