Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 144807; Drug: Ketoconazole

• Registration Number: NCT01707940
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 144807	BI 144807	subjects receive an oral single dose of BI 144807
BI 144807 plus Ketoconazole	Ketoconazole	subjects receive bid ketoconazole plus an oral single dose of BI 144807
BI 144807 plus Ketoconazole	BI 144807	subjects receive bid ketoconazole plus an oral single dose of BI 144807

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma	0 to 48 hours after administration

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point	0 to 48 hours after administration

Trial Locations

Locations (1)

1313.7.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany