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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017202-36 | EudraCT Number | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 | Experimental | 50 mg single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | 2 tablets BI 10773 25 mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to Infinity (AUC0-∞) | 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. | 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 (Cmax) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | 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. | 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. |
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Inclusion criteria:
Healthy males and females. Hepatically impaired male and female subjects. Age: 18 - 75 years, BMI: 18-34 kg/m2 Creatinine clearance >80 mL/min (except for patients with severe hepatic impairment, see exclusion criteria.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria:
Healthy subjects (group 1)
Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery.
Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min.
Chronic or relevant acute infections.
History of allergy/hypersensitivity.
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
Inability to refrain from smoking when confined to the study site on trial days.
Alcohol abuse, drug abuse.
Veins unsuited for iv puncture on either arm.
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities (within 48 hours prior to trial or during the trial).
Any laboratory value outside the reference range that is of clinical relevance.
Inability to comply with dietary regimen of study centre.
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Hepatically impaired subjects (group 2-4):
Decompensated gastrointestinal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
For patients with severe liver impairment (Child-Pugh C): Severe concurrent renal dysfunction (e.g., due to hepato-renal syndrome) and a creatinine clearance <40mL/min.
Relevant gastrointestinal tract surgery.
Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
Chronic or relevant acute infections.
History of allergy/hypersensitivity.
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co-medication known to inhibit or induce P-glycoprotein (such as quinidine, cyclosporine, amiodarone) is not allowed. In dubious cases, a case by case decision will be made after consultation with the sponsor.
Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
Inability to refrain from smoking when confined to the study site on trial days.
Alcohol abuse, Drug abuse.
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities (within 48 hours prior to trial or during the trial).
Clinically relevant laboratory abnormalities.
Inability to comply with dietary regimen of study centre.
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
For female subjects of all groups:
Pregnancy
Positive pregnancy test
No adequate contraception during the study and until 2 months after study completion.
Lactation period.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.13.40001 Boehringer Ingelheim Investigational Site | Timișoara | Romania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. |
| FG001 | Mild | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. |
| FG002 | Moderate | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. |
| FG003 | Severe | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. |
| BG001 | Mild |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve 0 to Infinity (AUC0-∞) | 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. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | nmol*h/L | 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 |
|
Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MEDDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Time From Dosing to Maximum Concentration (Tmax) | Time from dosing to maximum concentration of empagliflozin (empa) in plasma. | 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 (λz) | Terminal rate constant in plasma. The standard deviation is actually the coefficient of variation. | 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 (t1/2) | Terminal half-life of empagliflozin (empa) in plasma. The standard deviation is actually the coefficient of variation. | 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 (MRTpo) | Mean residence time of empagliflozin (empa) in the body. The standard deviation is actually the coefficient of variation. | 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 After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration. The standard deviation is actually the coefficient of variation. | 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 (Vz/F) | Apparent volume of distribution during the terminal phase (λz). The standard deviation is actually the coefficient of variation. | 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 |
| Amount of Empagliflozin That is Eliminated in Urine (Ae0-96) | 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. | 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 Excreted Unchanged in Urine (fe0-96)) | Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours. The standard deviation is actually the coefficient of variation. | 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 |
| Renal Clearance After Extravascular Administration (CL R) | Renal clearance of empagliflozin (empa) in plasma after extravascular administration. The standard deviation is actually the coefficient of variation. | 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 |
| Urinary Glucose Excretion (UGE) | Urinary glucose excretion, this endpoint was measured using Ae0-96. The standard deviation is actually the coefficient of variation. | 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 |
| Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator | 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). | Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days |
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. |
| BG002 | Moderate | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. |
| BG003 | Severe | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
| OG001 | Mild | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. |
| OG002 | Moderate | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. |
| OG003 | Severe | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C. |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) | 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. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | nmol/L | 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 |
|
|
|
|
| Secondary | Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | 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. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | nmol*h/L | 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. |
|
|
|
| Secondary | Time From Dosing to Maximum Concentration (Tmax) | Time from dosing to maximum concentration of empagliflozin (empa) in plasma. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Median | Full Range | h | 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. |
|
|
|
| Secondary | Terminal Rate Constant (λz) | Terminal rate constant in plasma. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | 1/h | 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 |
|
|
|
| Secondary | Terminal Half-Life (t1/2) | Terminal half-life of empagliflozin (empa) in plasma. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | h | 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 |
|
|
|
| Secondary | Mean Residence Time (MRTpo) | Mean residence time of empagliflozin (empa) in the body. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | h | 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 |
|
|
|
| Secondary | Apparent Clearance After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | mL/min | 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 |
|
|
|
| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Apparent volume of distribution during the terminal phase (λz). The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | L | 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 |
|
|
|
| Secondary | Amount of Empagliflozin That is Eliminated in Urine (Ae0-96) | 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. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | nmol | 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 |
|
|
|
| Secondary | Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96)) | Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | percentage of empagliflozin | 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 |
|
|
|
| Secondary | Renal Clearance After Extravascular Administration (CL R) | Renal clearance of empagliflozin (empa) in plasma after extravascular administration. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | mL/min | 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 |
|
|
|
| Secondary | Urinary Glucose Excretion (UGE) | Urinary glucose excretion, this endpoint was measured using Ae0-96. The standard deviation is actually the coefficient of variation. | Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax. | Posted | Mean | Standard Deviation | mg | 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 |
|
|
|
| Secondary | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator | 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). | Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment. | Posted | Number | participants | Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days |
|
|
|
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Mild | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. | 0 | 8 | 0 | 8 |
| EG002 | Moderate | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. | 0 | 8 | 3 | 8 |
| EG003 | Severe | Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C. | 0 | 8 | 2 | 8 |
| Constipation | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MEDDRA 13.1 | Systematic Assessment |
|
| Nitrite urine present | Investigations | MEDDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MEDDRA 13.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Ratio calculated as moderate divided by healthy | ANOVA | Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status). | Geometric mean ratio | 123.31 | Standard Deviation | 30.7 | 2-Sided | 90 | 97.74 | 155.55 | Standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability |
| Ratio calculated as severe divided by healthy | ANOVA | Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status). | Geometric mean ratio | 148.41 | Standard Deviation | 30.7 | 2-Sided | 90 | 117.65 | 187.23 | Standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability |
| Investigations: Nitrite urine present |
|