Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

Boehringer Ingelheim57 enrolled

Overview

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Asthma

Interventions

Placebo to BI 144807DRUG

multiple dose (bid)

BI 144807DRUG

multiple dose (bid, low to high dose)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion criteria: 1\. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential) Exclusion criteria: 1\. Apart from mild asthma any relevant deviation from healthy conditions

Locations (1)

1313.2.44001 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

Number (% patients) of drug-related adverse events

Time frame: up to 28 days

Secondary Outcomes

Maximum measured concentration of the analyte in plasma after first dose (Cmax)

Time frame: up to 24 hours after first dose

Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)

Time frame: up to 72 hours after last dose

Time from first dosing to maximum measured concentration (Tmax)

Time frame: up to 24 hours after first dose

Time from last dosing to maximum measured concentration (Tmax,ss)

Time frame: up to 72 hours after last dose

Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)

Time frame: up to 24 hours after first dose

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

Time frame: up to 72 hours after last dose

Terminal half-life of the analyte in plasma after the first dose (t1/2)

Time frame: up to 24 hours after first dose

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

Time frame: up to 72 hours after last dose

RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose)

Data from ClinicalTrials.gov

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