Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Solifenacin succinate suspension 2.5 mg; Solifenacin succinate suspension 5 mg; Solifenacin succinate suspension 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): YM905; YM905; YM905
Intervention MeSH terms: Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive bladder; Solifenacin suspension; Pharmacokinetics; Single-dose; Pediatric