DDI Between BI Empagliflozin (10773) and Verapamil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01276301
First received: January 12, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

Relative bioavailability of BI 10773 given alone and together with verapamil


Condition Intervention Phase
Healthy
Drug: Verapamil
Drug: BI 10773
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.

  • Maximum Measured Concentration (Cmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of empagliflozin (empa) in plasma.


Secondary Outcome Measures:
  • Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum plasma concentration

  • Terminal Elimination Rate Constant (λz) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    Terminal elimination rate constant in plasma.

    Note: The numbers provide below for standard deviation are of Coefficient of Variation.


  • Terminal Half-life in Plasma (t1/2) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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). [ Time Frame: Day1 to Day 11 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within Day 15 to Day 25 ] [ Designated as safety issue: No ]
    Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.


Other Outcome Measures:
  • Verapamil Plasma Concentration [ Time Frame: Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration ] [ Designated as safety issue: No ]

    Verapamil plasma concentration were measured in order to confirm exposure.

    Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ).



Enrollment: 16
Study Start Date: January 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
single dose BI 10773
Drug: BI 10773
single dose BI 10773
Active Comparator: Test
single dose BI 10773 + single dose verapamil
Drug: Verapamil
single dose verapamil
Drug: BI 10773
single dose BI 10773

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

healthy male and female 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: NCT01276301

Locations
Germany
1245.43.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01276301     History of Changes
Other Study ID Numbers: 1245.43, 2010-023059-27
Study First Received: January 12, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014