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Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 single rising dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 single rising dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 33 days | |
| Number of patients with clinically significant changes in vital signs | up to 12 days | |
| Assessment of tolerability by investigator on a 4-point scale | up to day 4 | |
| Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) | up to 12 days | |
| Number of patients with abnormal findings in physical examination | up to 12 days | |
| Number of patients with abnormal changes in laboratory parameters | up to 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| tmax (time from dosing to maximum concentration) | up to 72 hours after drug administration | |
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Inclusion Criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age ≥ 18 and Age ≤ 50 years
BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion Criteria:
Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
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 of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with the dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome);
Exclusion criteria specific for this study:
Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)
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|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
| up to 72 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 72 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 72 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after po administration) | up to 72 hours after drug administration |
| CL/F (total clearance of the analyte in the plasma after extravascular administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after drug administration |
| Ae t1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) | up to 72 hours after drug administration |
| fe t1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 72 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 72 hours after drug administration |