Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01480648

Enrollment

Registered

2011-11-29

Start date

2011-11-30

Completion date

Unknown

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

Healthy

Brief summary

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.

Interventions

DRUGBI 144807 Placebo

Placebo that represents BI drug

DRUGBI 144807

single dose (low to high dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1\. healthy male subjects

Exclusion criteria

1\. any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
Number of participants tolerating BI 144807	up to 14 days postdose
All adverse events	up to 14 days postdose
Number of participants with clinically significant changes in vital signs	up to 14 days postdose
Number of participants with clinically significant changes in ECG	up to 14 days postdose
Number of participants with clinically significant changes in laboratory tests	up to 14 days postdose
Number of participants with clinically significant changes in physical examination	up to 14 days postdose

Secondary

Measure	Time frame
tmax (time from dosing to maximum measured concentration)	up to 72h postdose
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72h postdose
AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)	up to 72h postdose
t1/2 (terminal half-life of the analyte in plasma)	up to 72h postdose
Cmax (maximum measured concentration of the analyte in plasma)	up to 72h postdose

Countries

Germany

Outcome results

None listed

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