Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707940

Enrollment

Registered

2012-10-16

Start date

2012-10-31

Completion date

2012-12-31

Last updated

2013-05-16

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

Conditions

Healthy

Brief summary

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

Interventions

DRUGKetoconazole

Ketoconazole 400 mg / day

DRUGBI 144807

BI144807 oral solution, intermediate dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 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
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma	0 to 48 hours after administration

Secondary

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	0 to 48 hours after administration

Countries

Germany

Outcome results

None listed

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