Phase 1
N=18
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01111331 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss) — 4580.38; 4621.37 nmol*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 10773 25 mg (Drug); Warfarin 25 mg (Drug); Warfarin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss) |
4580.38; 4621.37 | — |
| PRIMARY Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss) |
759.96; 764.82 | 0.0021 sig |
| PRIMARY Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) |
63585.71; 62626.35 | — |
| PRIMARY Warfarin R-enantiomers: Maximum Measured Concentration (Cmax) |
1404.07; 1374.40 | 0.0001 sig |
| PRIMARY Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞) |
37493.28; 35949.84 | — |
| PRIMARY Warfarin S-enantiomers: Maximum Measured Concentration (Cmax) |
1441.66; 1425.56 | 0.0001 sig |
| SECONDARY Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N) |
40.8; NA; NA; 41.6 | — |
| SECONDARY Empagliflozin: Terminal Rate Constant at Steady State (λz,ss) |
0.10; 0.10 | — |
| SECONDARY Empagliflozin: Terminal Half-life at Steady State (t1/2,ss) |
6.67; 7.07 | — |
| SECONDARY Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) |
1.50; 1.00 | — |
| SECONDARY Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss) |
8.64; 9.08 | — |
| SECONDARY Empagliflozin: Apparent Clearance at Steady State (CL/F,ss) |
187; 183 | — |
| SECONDARY Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss) |
108; 112 | — |
| SECONDARY Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) |
58556.93; 57911.05 | — |
| SECONDARY Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax) |
0.84; 1.00 | — |
| SECONDARY Warfarin R-enantiomers: Terminal Rate Constant (λz) |
0.0147; 0.0151 | — |
| SECONDARY Warfarin R-enantiomers: Terminal Half-life (t1/2) |
47.1; 45.8 | — |
| SECONDARY Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo) |
62.9; 61.2 | — |
| SECONDARY Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) |
6.55; 6.65 | — |
| SECONDARY Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) |
26.7; 26.4 | — |
| SECONDARY Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz) |
36386.49; 34962.95 | — |
| SECONDARY Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax) |
0.68; 0.84 | — |
| SECONDARY Warfarin S-enantiomers: Terminal Rate Constant (λz) |
0.0187; 0.0189 | — |
| SECONDARY Warfarin S-enantiomers: Terminal Half-life (t1/2) |
37.0; 36.7 | — |
| SECONDARY Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo) |
40.8; 38.9 | — |
| SECONDARY Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F) |
11.1; 11.6 | — |
| SECONDARY Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F) |
35.6; 36.8 | — |
| SECONDARY Warfarin: Peak International Normalised Ratio (INRmax) |
1.76; 1.53 | — |
| SECONDARY Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz) |
202.54; 178.08 | — |
| SECONDARY Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base) |
0.69; 0.69 | — |
| SECONDARY Warfarin: Peak Prothrombin Time (PTmax) |
20.17; 18.07 | — |
| SECONDARY Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base) |
32.42; 36.30 | — |
| SECONDARY Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz) |
2508.34; 2281.54 | — |
| SECONDARY Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base) |
6.69; 6.51 | — |
| SECONDARY Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base) |
419.24; 354.97 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator |
0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion criteria
Healthy male subjects
Data sourced from ClinicalTrials.gov (NCT01111331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.