Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
- Registration Number
- NCT01111318
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 BI 10773 50 mg single dose
- Primary Outcome Measures
Name Time Method Maximum Measured Concentration (Cmax) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Maximum measured concentration of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.Area Under the Curve 0 to Infinity (AUC0-∞) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
- Secondary Outcome Measures
Name Time Method Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96)) Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.
The standard deviation is actually the coefficient of variation.Renal Clearance After Extravascular Administration (CL R) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Renal clearance of empagliflozin (empa) in plasma after extravascular administration.
The standard deviation is actually the coefficient of variation.Urinary Glucose Excretion (UGE) Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration Urinary glucose excretion, this endpoint was measured using Ae0-96.
The standard deviation is actually the coefficient of variation.Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration. Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
The standard deviation is actually the coefficient of variation.Time From Dosing to Maximum Concentration (Tmax) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration. Time from dosing to maximum concentration of empagliflozin (empa) in plasma.
Terminal Rate Constant (λz) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Terminal rate constant in plasma.
The standard deviation is actually the coefficient of variation.Terminal Half-Life (t1/2) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Terminal half-life of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation.Mean Residence Time (MRTpo) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Mean residence time of empagliflozin (empa) in the body.
The standard deviation is actually the coefficient of variation.Apparent Clearance After Extravascular Administration (CL/F) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.
The standard deviation is actually the coefficient of variation.Apparent Volume of Distribution During the Terminal Phase (Vz/F) Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration Apparent volume of distribution during the terminal phase (λz).
The standard deviation is actually the coefficient of variation.Amount of Empagliflozin That is Eliminated in Urine (Ae0-96) Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.
The standard deviation is actually the coefficient of variation.Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).
Trial Locations
- Locations (1)
1245.13.40001 Boehringer Ingelheim Investigational Site
🇷🇴Timisoara, Romania