Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 187004

• Registration Number: NCT02161432
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment C	BI 187004	single dose of BI 187004 in fed state
Treatment A	BI 187004	single dose of BI 187004 in fasted state
Treatment B	BI 187004	single dose of BI 187004

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma) of BI 187004	up to 17 days postdose
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004	up to 17 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)	up to 17 days postdose

Trial Locations

Locations (1)

1307.3.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany