A Phase 1 interventional study of Solifenacin succinate suspension 2.5 mg and Solifenacin succinate suspension 5 mg in Urinary Bladder, Overactive, sponsored by Astellas Pharma Inc. Completed at 8 sites in 4 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.
This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.
The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 42 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Exclusion Criteria:
Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 2.5 mg
Male and female adolescents aged 12 to less than 18 years old who receive PED of 5 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 5 mg
Male and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 10 mg
Male and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 2.5 mg
Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 5 mg
Male and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate.
Drug: Solifenacin succinate suspension 10 mg
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 doses of 2.5 mg of solifenacin once daily in adults.
Also known as: YM905
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 doses of 5 mg dose of solifenacin once daily in adults.
Also known as: YM905
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 doses 10 mg dose of solifenacin once daily in adults.
Also known as: YM905
Maximum Concentration (Cmax)
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
Time to Attain Cmax (tmax)
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
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
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.
Time frame: From the first dose of study drug up to 7 days postdose
Change from baseline in postvoid residual (PVR) volume
PVR volume is assessed by ultrasonography or bladder scan.
Time frame: Baseline (screening) and 4 hours postdose
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc