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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 113823; Drug: BI 113823 + Ketokonazole

• Registration Number: NCT01189175
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2010-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 113823	BI 113823	single oral dose per subject
BI 113823 + Ketokonazole	BI 113823 + Ketokonazole	after wash-out 5 days ketokonazole with BI 113823 on day 3

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of participants with clinically significant changes in physical examination	up to 24 days
Number of participants with clinically significant changes in vital signs	up to 24 days
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
tmax (time from dosing to the maximum concentration of the analyte in plasma)	2 weeks
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
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
Assessment of tolerability by the investigator	up to 24 days
AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax	2 weeks
Occurrence of adverse events	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
λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma	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

Trial Locations

Locations (1)

1272.5.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany