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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01286571
First received: January 28, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BI 135585
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • Physical examination (occurrence of findings) [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 144 hours post treatment ] [ Designated as safety issue: No ]
  • Vital signs (blood pressure, pulse rate) [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • 12-lead ECG (electrocardiogram) [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis) [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • Incidence and severity of Adverse events [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • Assessment of tolerability by the investigator [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

- healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286571

Locations
Germany
1283.3.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01286571     History of Changes
Other Study ID Numbers: 1283.3, 2010-022697-14
Study First Received: January 28, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 17, 2014