drugset / Trial / 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)

NCT02526979

Phase 1 Completed 9 enrolled Astellas Pharma Europe B.V.
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2015-12-17
Primary completion
2016-09-30
Completion
2016-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirabegron Other / unclassified Oral

Indications