Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 425809; Drug: Itraconazole

• Registration Number: NCT02342717
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reference	BI 425809	single dose BI 425809
Test	BI 425809	multiple doses of Itraconazole + single dose BI 425809
Test	Itraconazole	multiple doses of Itraconazole + single dose BI 425809

Primary Outcome Measures

Name	Time	Method
AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h)	8 days postdose
Cmax (maximum measured concentration of the analyte in plasma)	15 days postdose

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	15 days postdose

Trial Locations

Locations (1)

1346.10.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany