Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01111331
First received: April 26, 2010
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.


Condition Intervention Phase
Healthy
Drug: BI 10773 25 mg
Drug: Warfarin 25 mg
Drug: Warfarin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Both BI 10773 and Warfarin and Pharmacodynamics of Warfarin After Co-administration Compared to Multiple Oral Doses of BI 10773 (25 mg qd) and a Single Oral Dose of Warfarin (25mg) Alone in Healthy Male Volunteers (an Open-label,Crossover, Clinical Phase I Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC(tau,ss) (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • C(max,ss) (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • AUC(0-infinity) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • C(max) (maximum measured concentration of the analyte in plasma) of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • time from dosing to the maximum concentration of the analyte in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • terminal rate constant in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • mean residence time of the analyte in the body after po administration of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent clearance of the analyte in the plasma after extravascular administration of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • apparent volume of distribution during the terminal phase following an extravascular dose of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma at steady state of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • mean residence time of the analyte in the body at steady state after oral administration of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • apparent clearance of the analyte in the plasma after extravascular administration at steady state of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • apparent volume of distribution during the terminal phase at steady state following extravascular administration of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Prothrombin Time (PT) as International Normalised Ratio (INR) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 25 mg
1 tablet 25 mg BI 10773 qd for 5 days
Drug: BI 10773 25 mg
25 mg BI 10773 qd for 12 days
Experimental: BI 10773 25 mg + Warfarin 25 mg
1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose
Drug: BI 10773 25 mg
25 mg BI 10773 qd for 5 days
Drug: Warfarin 25 mg
25 mg Warfarin single dose
Active Comparator: Warfarin 25 mg
5 tablets 5 mg warfarin single dose
Drug: Warfarin
25 mg warfarin single dose with and without 50 mg BI 10773

  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

  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: NCT01111331

Locations
Germany
1245.18.1 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
ClinicalTrials.gov Identifier: NCT01111331     History of Changes
Other Study ID Numbers: 1245.18, 2009-018088-29
Study First Received: April 26, 2010
Last Updated: October 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014