Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 144807 intermediate dose; Drug: BI 144807 high dose

• Registration Number: NCT01897597
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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
BI 144807 PfoS Treatment A	BI 144807 intermediate dose	intermediate dose of BI 144807
BI 144807 PfoS Treatment C	BI 144807 high dose	high dose of BI 144807
BI 144807 Tab Treatment B	BI 144807 intermediate dose	intermediate dose of BI 144807
BI 144807 Tab Treatment D	BI 144807 high dose	high dose of BI 144807
BI 144807 Tab Treatment E	BI 144807 intermediate dose	intermediate dose of BI 144807, fasted
BI 144807 Tab Treatment F	BI 144807 intermediate dose	intermediate dose of BI 144807, fed
BI 144807 Tab Treatment G	BI 144807 intermediate dose	intermediate dose of BI 144807, fasted

Primary 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 (AUC0-tz)	48 hours
Maximum measured concentration of the analyte in plasma (Cmax)	48 hours

Secondary 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 (AUC0-inf)	48 hours

Trial Locations

Locations (1)

1313.9.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany