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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT01629849

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

84 participants

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)

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Number of subjects with drug-related adverse events [up to day 22]

Secondary Outcome Measures

Cmax (maximum measured concentration of the analyte in plasma) [up to 481:30 h]
tmax (time from dosing to maximum measured concentration of the analyte in plasma) [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) [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) [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) [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 [up to 481:30 h]
terminal rate constant in plasma [up to 481:30 h]
MRTpo (mean residence time of the analyte in the body after oral administration) [up to 481:30 h]
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) [up to 481:30 h]
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [up to 481:30 h]
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) [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) [up to 481:30 h]
terminal rate constant in plasma at steady state [up to 481:30 h]
t1/2,ss (terminal half-life of the analyte in plasma at steady state) [up to 481:30 h]
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [up to 481:30 h]
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) [up to 481:30 h]
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) [up to 481:30 h]
Cavg (average concentration) [up to 481:30 h]
PTF (peak trough fluctuation) [up to 481:30 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Healthy male and female subjects ofn non child-bearing potential

Exclusion criteria:

Any relevant deviation from healthy conditions except mild controlled asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1310.2.1 Boehringer Ingelheim Investigational Site	Gauting		Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01629849

Other Study ID Numbers:

1310.2
2012-000926-23

First Posted:

Jun 28, 2012

Last Update Posted:

May 16, 2013

Last Verified:

May 1, 2013

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of May 16, 2013