DDI Between BI Empagliflozin (10773) and Verapamil

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773; Drug: Verapamil

• Registration Number: NCT01276301
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Relative bioavailability of BI 10773 given alone and together with verapamil

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2011-02
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	BI 10773	single dose BI 10773
Test	BI 10773	single dose BI 10773 + single dose verapamil
Test	Verapamil	single dose BI 10773 + single dose verapamil

Primary Outcome Measures

Name	Time	Method
Area Under the Curve 0 to Infinity (AUC0-∞)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.
Maximum Measured Concentration (Cmax)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Maximum measured concentration of empagliflozin (empa) in plasma.

Secondary Outcome Measures

Name	Time	Method
Terminal Elimination Rate Constant (λz)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Terminal elimination rate constant in plasma.; Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.
Time From 0 to Maximum Plasma Concentration (Tmax)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Time from last dosing to the maximum plasma concentration
Terminal Half-life in Plasma (t1/2)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Terminal half-life of empagliflozin in plasma.; Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Mean Residence Time in the Body After Administration (MRTpo)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Mean residence time of empagliflozin (empa) in the body after oral administration.; Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Apparent Clearance in Plasma After Extravascular Administration (CL/F)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.; Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)	0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration	Apparent volume of distribution during the terminal phase following an extravascular dose.; Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).	Day1 to Day 11	Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.
Assessment of Tolerability by Investigator	Within Day 15 to Day 25	Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.

Trial Locations

Locations (1)

1245.43.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany