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Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KUC 7483 CL | Experimental | increasing repeated oral doses |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KUC 7483 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal findings in physical examination | up to 8 days after last drug administration | |
| Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram) | up to 8 days after last drug administration | |
| Number of subjects with clinically significant changes in vital signs | Blood Pressure, Pulse Rate, body temperature, orthostatic testing | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in laboratory tests | up to 8 days after last drug administration | |
| Changes in salivary secretion | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 | |
| Changes in residual urine volume | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 | |
| Number of subjects with adverse events | up to 8 days after last drug administration | |
| Assessment of tolerability by investigator on a 5-point 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, Potassium, Lactate and cAMP |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | up to day 9 | |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | up to day 9 | |
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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 ≥21 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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|
| up to day 8 |
| Area under the concentration-time curve of the analyte in plasma (AUC) |
| up to day 9 |
| Terminal rate constant of the analyte constant in plasma (λz) | up to day 9 |
| Terminal half-life of the analyte in plasma (t1/2) | up to day 9 |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | up to day 9 |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | up to day 9 |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | up to day 9 |
| Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2) | up to day 9 |
| Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2) | up to day 9 |
| Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2) | up to day 9 |
| Minimum concentration of the analyte in plasma at steady state (Cmin,ss ) | up to day 9 |
| Accumulation ratio (RA) | up to day 9 |
| Linearity index (LI) | up to day 9 |