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OpenTrials
Completed

NCT Number: NCT01276301

DDI Between BI Empagliflozin (10773) and Verapamil

Relative bioavailability of BI 10773 given alone and together with verapamil

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1245.43.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

Treatment and study plan

Verapamil

Drug

single dose verapamil

BI 10773

Drug

single dose BI 10773

Primary outcomes

  1. 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

    Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.

  2. 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

    Maximum measured concentration of empagliflozin (empa) in plasma.

Secondary outcomes

  1. 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

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.

  2. 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

    Time from last dosing to the maximum plasma concentration

  3. 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

    Terminal elimination rate constant in plasma.

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

  4. 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

    Terminal half-life of empagliflozin in plasma.

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

  5. 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

    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.

  6. 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

    Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.

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

  7. 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

    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.

  8. Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).

    Time frame: 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.

  9. Assessment of Tolerability by Investigator

    Time frame: 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.

Other outcomes

  1. Verapamil Plasma Concentration

    Time frame: Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration

    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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
First posted
Jan 13, 2011
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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