Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 135585

• Registration Number: NCT01286571
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2011-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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 135585 (T)	BI 135585	single dose per subject as tablet formulation after high fat, high caloric meal
BI 135585 (R)	BI 135585	single dose per subject as tablet formulation after an overnight fast

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity	up to 144 hours post treatment
Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity	up to 144 hours post treatment

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of Adverse events	up to 14 days post treatment
t1/2 (terminal half-life of the analyte in plasma)	up to 144 hours post treatment
Vital signs (blood pressure, pulse rate)	up to 14 days post treatment
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)	up to 144 hours post treatment
%AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)	up to 144 hours post treatment
λz (terminal rate constant in plasma)	up to 144 hours post treatment
MRTpo (mean residence time of the analyte in the body after oral administration)	up to 144 hours post treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 144 hours post treatment
Physical examination (occurrence of findings)	up to 14 days post treatment
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)	up to 144 hours post treatment
Assessment of tolerability by the investigator	up to 14 days post treatment
tmax (time from dosing to maximum measured concentration)	up to 144 hours post treatment
12-lead ECG (electrocardiogram)	up to 14 days post treatment
Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)	up to 14 days post treatment

Trial Locations

Locations (1)

1283.3.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany