The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
Site: 3201
Ghent, Belgium
Unnamed facility
Québec, Quebec, Canada
Site: 4501
Århus N, Denmark
Site: 3102
Utrecht, Netherlands
Maximum concentration (Cmax)
Time frame: Day 1 predose up to Day 7 postdose
Time to Attain Cmax (tmax)
Time frame: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Terminal Elimination Half-life (t1/2)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Total Body Clearance (CL/F)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Time frame: Day 1 predose up to Day 7 postdose
Number of Participants with Adverse Events (AEs)
Safety is monitored by collecting AEs, which includes abnormal laboratory tests, vital signs or ECG data that are defined as an AE if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study medication or is clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) is defined as an AE that occurs or worsens after study drug administration. A serious AE (SAE) is any untoward medical occurrence that, at any dose: Results in death, is life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events.
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Site: 4801
Warsaw, Poland
Site: 90
Ankara, Turkey (Türkiye)
Site: 44
Sheffield, United Kingdom
Time frame: From the first dose of study drug up to 7 days postdose