Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

An Open-label, Single Dose, Randomised, Crossover Trial in Healthy Male Subjects to Investigate the Relative Bioavailability of Tablet and Oral Solution of Two Doses of BI 144807 and Relative Bioavailability of BI 144807 When Administered as Tablet Under Fed and Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897597

Enrollment

Registered

2013-07-12

Start date

2013-07-31

Completion date

2013-09-30

Last updated

2013-09-06

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

Conditions

Healthy

Brief summary

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Interventions

DRUGBI 144807 high dose

oral solution

DRUGBI 144807 intermediate dose

tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

\- Healthy male subjects

Exclusion criteria

\- Any relevant deviation from healthy condition

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	48 hours
Maximum measured concentration of the analyte in plasma (Cmax)	48 hours

Secondary

Measure	Time frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)	48 hours

Countries

Germany

Outcome results

None listed

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