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Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KUC 7483 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KUC 7483 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in "volume at first contraction" | 2 hours post dosing | |
| Change from baseline in "volume at first contraction" | 6 hours post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Detrusor pressure at first contraction | 2 and 6 hours post dosing | |
| Change from baseline in Maximum amplitude of involuntary detrusor contraction | 2 and 6 hours post dosing |
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Exclusion Criteria:
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|
| Change from baseline in Volume at first incontinence episode | 2 and 6 hours post dosing |
| Change from baseline in compliance | 2 and 6 hours post dosing |
| Change from baseline in Maximum cystometric capacity | 2 and 6 hours post dosing |
| Change from baseline in Detrusor pressure at maximum flow induced by triggering | 2 and 6 hours post dosing |
| Change from baseline in Post-triggering residual urinary volume | 2 and 6 hours post dosing |
| AUC0-∞ (area under the concentration time curve of KUC 7322 ZW in plasma over the time interval from 0 extrapolated to infinity) | up to 24 hours post dosing |
| Cmax (maximum concentration of KUC 7322 ZW in plasma) | up to 24 hours post dosing |
| AUC0-tz (area under the concentration-time curve of KUC 7322 ZW in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 24 hours post dosing |
| AUC0-24 (Area under the concentration time curve of KUC 7322 ZW in plasma over the time interval 0 to 24 hours) | up to 24 hours post dosing |
| tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma) | up to 24 hours post dosing |
| λz (terminal rate constant of KUC 7322 ZW in plasma) | up to 24 hours post dosing |
| t1/2 (terminal half-life of KUC 7322 ZW in plasma) | up to 24 hours post dosing |
| MRTpo (mean residence time of KUC 7322 ZW in the body after po administration) | up to 24 hours post dosing |
| CL/F (apparent clearance of KUC 7322 ZW in the plasma after extravascular administration) | up to 24 hours post dosing |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 24 hours post dosing |
| Aet1-t2 (amount of KUC 7322 ZW that is eliminated in urine from the time interval t1 to t2) | up to 24 hours post dosing |
| fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2) | up to 24 hours post dosing |
| CLR,t1-t2 (renal clearance of KUC 7322 ZW in plasma from the time point t1 until the time point t2) | up to 24 hours post dosing |
| Number of patients with adverse events | up to 26 days |
| Number of patients with clinically significant changes in vital signs | Blood Pressure | up to 24 hours post dosing |
| Assessment of tolerability by investigator on a 4-point scale | 10 days post dosing |
| Assessment of tolerability by patient on a 4-point scale | 10 days post dosing |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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