Clinical Trials/NCT02211846

NCT02211846

Completed

Phase 1

A Multicentre, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS Tablets in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

Astellas Pharma Inc13 sites in 5 countries34 target enrollmentSeptember 21, 2014

ConditionsNeurogenic Detrusor Overactivity Overactive Bladder Pharmacokinetics of Mirabegron

InterventionsMirabegron

DrugsMirabegron

Overview

Phase: Phase 1
Intervention: Mirabegron
Conditions: Neurogenic Detrusor Overactivity
Sponsor: Astellas Pharma Inc
Enrollment: 34
Locations: 13
Primary Endpoint: Pharmacokinetic parameter of mirabegron: t1/2
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.

Registry

clinicaltrials.gov

Start Date

September 21, 2014

End Date

September 21, 2015

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has a documented diagnosis of:
•Neurogenic detrusor overactivity (NDO), or
•Idiopathic overactive bladder (OAB) according to International Children's Continence Society (ICCS) criteria.
•Subject's weight/height:
•Subject should have a body weight of ≥ 20.0 kg (all cohorts).
•For NDO: subject is not suffering from malnutrition and is not severely overweight, in the opinion of the Investigator.
•For OAB: subject's weight and height are within the normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts.
•Subject is able to swallow the study medication in accordance with the protocol.
•Female subject must either:
•Be of non-childbearing potential:

Exclusion Criteria

Not provided

Arms & Interventions

Mirabegron

Administered under fed and fasted conditions

Intervention: Mirabegron

Outcomes

Primary Outcomes

Pharmacokinetic parameter of mirabegron: t1/2

Time Frame: Day 1-7

Apparent terminal elimination half-life (t1/2 )

Pharmacokinetic parameter of mirabegron: Cmax

Time Frame: Day 1-7

Maximum concentration (Cmax)

Pharmacokinetic parameter of mirabegron: tmax

Time Frame: Day 1-7

The time after dosing when Cmax occurs (tmax)

Pharmacokinetic parameter of mirabegron: AUCinf

Time Frame: Day 1-7

Area under the curve extrapolated until time is infinity (AUCinf)

Secondary Outcomes

Safety as assessed by adverse events, clinical laboratory evaluations, vital signs (including 24-h Holter for heart rate), electrocardiogram (ECG), physical examination, post-void residual volume (PVR)(up to Day 7)