Study in Healthy Male Subjects to Investigate Whether Ketoconazole Affects Plasma Exposure of BI 113823

Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01189175

Enrollment

Registered

2010-08-26

Start date

2010-08-31

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

The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Interventions

DRUGBI 113823 + Ketokonazole

5 days ketokonazole with single oral dose of BI 113823 on day 3

DRUGBI 113823

single oral 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

healthy male subjects

Design outcomes

Primary

Measure	Time frame
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823	2 weeks
Cmax (maximum measured concentration of the analyte in plasma) of BI 113823	2 weeks

Secondary

Measure	Time frame
Number of participants with clinically significant changes in vital signs	up to 24 days
Number of participants with clinically significant changes in ECG	up to 24 days
Number of participants with clinically significant changes in laboratory tests	up to 24 days
Occurrence of adverse events	up to 24 days
Assessment of tolerability by the investigator	up to 24 days
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)	2 weeks
AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax	2 weeks
tmax (time from dosing to the maximum concentration of the analyte in plasma)	2 weeks
AUC0-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)	2 weeks
t1/2 (terminal half-life of the analyte in plasma)	2 weeks
MRTpo (mean residence time of the analyte in the body after po administration)	2 weeks
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)	2 weeks
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	2 weeks
Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)	visit 2, day 1 and visit 4 day 1
fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24	visit 2, day 1 and visit 4 day 1
CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)	visit 2, day 1 and visit 4 day 1
λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma	2 weeks
Number of participants with clinically significant changes in physical examination	up to 24 days

Countries

Germany

Outcome results

None listed

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