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Study to investigate safety, tolerability and pharmacokinetics of KUC 7483
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KUC 7483 CL | Experimental | single rising doses |
|
| KUC 7483 CL, fed | Experimental | dosing after high fat meal |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KUC 7483 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant findings in physical examination | up to 8 days after last drug administration | |
| Number of subjects with clinically significant changes in vital signs | Blood pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram) | up to 8 days after last drug administration | |
| Number of subjects with clinically significant changes in laboratory parameters | up to 8 days after last drug administration | |
| Number of subjects with adverse events | up to 8 days after last drug administration | |
| Assessment of tolerability by investigator on a 3-point rating scale | within 8 days after last drug administration | |
| Number of subjects with clinically significant changes in special laboratory parameters | Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 48 hours after drug administration | |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 48 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 (BP, PR), 12-lead ECG, clinical laboratory tests
Age ≥30 and Age ≤60 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 and the local legislation
Exclusion Criteria:
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|
| High fat meal | Other |
|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 48 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 last quantifiable data point) | up to 48 hours after drug administration |
| λz (terminal rate constant of the analyte constant in plasma) | up to 48 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 48 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 48 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 48 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 48 hours after drug administration |
| Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 until time point t2) | up to 48 hours after drug administration |
| fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2) | up to 48 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2) | up to 48 hours after drug administration |