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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014