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

Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651598

Enrollment

Registered

2012-07-27

Start date

2012-07-31

Completion date

2013-01-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Healthy

Brief summary

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

Interventions

DRUGPlacebo to BI 144807

multiple dose (bid)

DRUGBI 144807

multiple dose (bid, low to high dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number (% patients) of drug-related adverse events	up to 28 days

Secondary

Measure	Time frame
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)	up to 72 hours after last dose
Time from first dosing to maximum measured concentration (Tmax)	up to 24 hours after first dose
Time from last dosing to maximum measured concentration (Tmax,ss)	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)	up to 24 hours after first dose
Maximum measured concentration of the analyte in plasma after first dose (Cmax)	up to 24 hours after first dose
Terminal half-life of the analyte in plasma after the first dose (t1/2)	up to 24 hours after first dose
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)	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)	up to 72 hours after last dose
RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose)	up to 72 hours after last dose
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)	up to 72 hours after last dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026