Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 113608; Drug: Ketoconazole; Drug: Voriconazole

• Registration Number: NCT01787032
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2016-11-23
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-25
• Last Update Submitted: 2017-01-25
• Results First Posted: 2017-03-15
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 3: BI 113608+Voriconazole	BI 113608	tablets with 240 ml water
Period 2: BI 113608+Ketoconazole	Ketoconazole	tablets with 240 ml water
Period 1: BI 113608	BI 113608	tablets with 240 ml water
Period 2: BI 113608+Ketoconazole	BI 113608	tablets with 240 ml water
Period 3: BI 113608+Voriconazole	Voriconazole	tablets with 240 ml water

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 113608 in Plasma (Cmax)	1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.	This outcome measure presents the maximum measured concentration of BI 113608 in plasma.; The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).; Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) \[%\]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) \[%\].
Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.	This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point.; The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).; Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) \[%\]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) \[%\].

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.	This outcome measure presents area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to infinity.; The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).; Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) \[%\]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) \[%\].
Terminal Half-life of BI 113608 in Plasma (t1/2)	1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.	This outcome measure presents terminal half-life of BI 113608 in plasma.
Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)	1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.	This outcome measure presents time from dosing to maximum measured concentration of BI 113608 in plasma.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany