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

Boehringer Ingelheim84 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Asthma

Interventions

Placebo to BI 1021958 qdDRUG

tablet

BI 1021958 bidDRUG

tablets

Placebo to BI 1021958 bidDRUG

tablets

BI 1021958 qd

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

1310.2.1 Boehringer Ingelheim Investigational Site

Gauting, Germany

Outcomes

Primary Outcomes

Number of subjects with drug-related adverse events

Time frame: up to day 22

Secondary Outcomes

Cmax (maximum measured concentration of the analyte in plasma)

Time frame: up to 481:30 h

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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: up to 481:30 h

terminal rate constant in plasma

Time frame: up to 481:30 h

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

Time frame: up to 481:30 h

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

Data from ClinicalTrials.gov

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