NCT02526979

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

A Multicentre, Open-Label, Single Dose, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB). This study will also evaluate the safety and tolerability as well as the acceptability and palatability of mirabegron oral suspension after single dose administration in children with NDO or OAB.

Conditions

• Overactive Bladder
• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	mirabegron	oral

Timeline

• Start date: 2015-12-17
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2015-08-18
• Last updated: 2024-10-31

Locations

3 sites across 2 countries: Denmark, Poland