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

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629849
• Other study ID #: 1310.2
• Secondary ID: 2012-000926-23
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2012
• Last updated: May 15, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Healthy

Intervention

Drug:
• Placebo to BI 1021958 qd
tablet
• BI 1021958 bid
tablets
• Placebo to BI 1021958 bid
tablets
• BI 1021958 qd
tablet

Locations

Country	Name	City	State
Germany	1310.2.1 Boehringer Ingelheim Investigational Site	Gauting

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with drug-related adverse events		up to day 22	Yes
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		up to 481:30 h	No
Secondary	tmax (time from dosing to maximum measured concentration of the analyte in plasma)		up to 481:30 h	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	terminal rate constant in plasma		up to 481:30 h	No
Secondary	MRTpo (mean residence time of the analyte in the body after oral administration)		up to 481:30 h	No
Secondary	Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)		up to 481:30 h	No
Secondary	tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)		up to 481:30 h	No
Secondary	Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)		up to 481:30 h	No
Secondary	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	No
Secondary	terminal rate constant in plasma at steady state		up to 481:30 h	No
Secondary	t1/2,ss (terminal half-life of the analyte in plasma at steady state)		up to 481:30 h	No
Secondary	MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)		up to 481:30 h	No
Secondary	CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)		up to 481:30 h	No
Secondary	Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)		up to 481:30 h	No
Secondary	Cavg (average concentration)		up to 481:30 h	No
Secondary	PTF (peak trough fluctuation)		up to 481:30 h	No