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

Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 135585

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1283.3.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

- healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 135585 (T); single dose per subject as tablet formulation after high fat, high caloric meal	Drug: BI 135585; one oral single dose per subject
Experimental: BI 135585 (R); single dose per subject as tablet formulation after an overnight fast	Drug: BI 135585; one oral single dose per subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Physical examination (occurrence of findings)	up to 14 days post treatment
%AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)	up to 144 hours post treatment
tmax (time from dosing to maximum measured concentration)	up to 144 hours post treatment
λz (terminal rate constant in plasma)	up to 144 hours post treatment
t1/2 (terminal half-life of the analyte 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
CL/F (total/apparent clearance of the analyte in plasma after extravascular 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
Vital signs (blood pressure, pulse rate)	up to 14 days 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
Incidence and severity of Adverse events	up to 14 days post treatment
Assessment of tolerability by the investigator	up to 14 days post treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 1283.3; 2010-022697-14 (EudraCT Number: EudraCT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No