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

Primary Purpose

Healthy, Asthma

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Placebo to BI 1021958 qd

BI 1021958 bid

Placebo to BI 1021958 bid

BI 1021958 qd

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

1310.2.1 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

BI 1021958 qd

Placebo to BI 1021958 qd

BI 1021958 bid

Placebo to BI 1021958 bid

Arm Description

Multiple rising dose

Matching placebo as tablets

Multiple rising dose

Matching palcebo as tablet

Outcomes

Primary Outcome Measures

Number of subjects with drug-related adverse events

Secondary Outcome Measures

Cmax (maximum measured concentration of the analyte in plasma)

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

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)

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)

AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered

terminal rate constant in plasma

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

Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)

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

Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)

AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)

terminal rate constant in plasma at steady state

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

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

CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)

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

Cavg (average concentration)

PTF (peak trough fluctuation)

Full Information

NCT ID

NCT01629849

First Posted

June 21, 2012

Last Updated

May 15, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01629849

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 1021958 qd

Arm Type

Experimental

Arm Description

Multiple rising dose

Arm Title

Placebo to BI 1021958 qd

Arm Type

Placebo Comparator

Arm Description

Matching placebo as tablets

Arm Title

BI 1021958 bid

Arm Type

Experimental

Arm Description

Multiple rising dose

Arm Title

Placebo to BI 1021958 bid

Arm Type

Placebo Comparator

Arm Description

Matching palcebo as tablet

Intervention Type

Drug

Intervention Name(s)

Placebo to BI 1021958 qd

Intervention Description

tablet

Intervention Type

Drug

Intervention Name(s)

BI 1021958 bid

Intervention Description

tablets

Intervention Type

Drug

Intervention Name(s)

Placebo to BI 1021958 bid

Intervention Description

tablets

Intervention Type

Drug

Intervention Name(s)

BI 1021958 qd

Intervention Description

tablet

Primary Outcome Measure Information:

Title

Number of subjects with drug-related adverse events

Time Frame

up to day 22

Secondary Outcome Measure Information:

Title

Cmax (maximum measured concentration of the analyte in plasma)

Time Frame

up to 481:30 h

Title

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

Time Frame

up to 481:30 h

Title

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

Title

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

Title

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

Title

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

Title

terminal rate constant in plasma

Time Frame

up to 481:30 h

Title

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

Time Frame

up to 481:30 h

Title

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

Title

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

Time Frame

up to 481:30 h

Title

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

Title

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

Title

terminal rate constant in plasma at steady state

Time Frame

up to 481:30 h

Title

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

Time Frame

up to 481:30 h

Title

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

Time Frame

up to 481:30 h

Title

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

Title

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

Time Frame

up to 481:30 h

Title

Cavg (average concentration)

Time Frame

up to 481:30 h

Title

PTF (peak trough fluctuation)

Time Frame

up to 481:30 h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1310.2.1 Boehringer Ingelheim Investigational Site

City

Gauting

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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