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

Study Overview
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Brief Summary
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The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 113823 + Ketokonazole
* Drug: BI 113823


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: healthy male subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 113823<br>single oral dose per subject | Drug: BI 113823<br>* single oral dose<br>|
| Experimental: BI 113823 + Ketokonazole<br>after wash-out 5 days ketokonazole with BI 113823 on day 3 | Drug: BI 113823 + Ketokonazole<br>* 5 days ketokonazole with single oral dose of BI 113823 on day 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma |  | 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 |