NCT01111331

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2014

Completed
Last Updated

July 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

April 26, 2010

Results QC Date

May 16, 2014

Last Update Submit

June 25, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss)

    Area under the plasma concentration-time curve for the dosing interval τ at steady state In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.

  • Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss)

    Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state. In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.

  • Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin

  • Warfarin R-enantiomers: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin

  • Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin

  • Warfarin S-enantiomers: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin

Secondary Outcomes (30)

  • Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N)

    24 hours after dose 4 or 6 respectively (day 5 and day 7)

  • Empagliflozin: Terminal Rate Constant at Steady State (λz,ss)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.

  • Empagliflozin: Terminal Half-life at Steady State (t1/2,ss)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.

  • Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin

  • Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss)

    0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.

  • +25 more secondary outcomes

Study Arms (3)

BI 10773 25 mg

EXPERIMENTAL

1 tablet 25 mg BI 10773 qd for 5 days

Drug: BI 10773 25 mg

BI 10773 25 mg + Warfarin 25 mg

EXPERIMENTAL

1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose

Drug: BI 10773 25 mgDrug: Warfarin 25 mg

Warfarin 25 mg

ACTIVE COMPARATOR

5 tablets 5 mg warfarin single dose

Drug: Warfarin

Interventions

BI 10773 25 mgDRUG

25 mg BI 10773 qd for 5 days

BI 10773 25 mg + Warfarin 25 mg
Warfarin 25 mgDRUG

25 mg Warfarin single dose

BI 10773 25 mg + Warfarin 25 mg
WarfarinDRUG

25 mg warfarin single dose with and without 50 mg BI 10773

Warfarin 25 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1245.18.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

empagliflozinWarfarin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 27, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2010

Last Updated

July 23, 2014

Results First Posted

July 23, 2014

Record last verified: 2014-06

Locations

DE(1)