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

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy; Asthma
• Intervention / Treatment: Drug: BI 1021958 qd; Drug: Placebo to BI 1021958 qd; Drug: BI 1021958 bid; Drug: Placebo to BI 1021958 bid

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Gauting, Germany
    • 1310.2.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with drug-related adverse events	up to day 22

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1310.2; 2012-000926-23 (EudraCT Number: EudraCT)