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 | Completed Phase 1

• 2 other identifiers: 178-CL-2032015-000700-26
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

OAB; overactive bladder; Myrbetric; neurogenic detrusor overactivity; Betanis; Myrbetriq; NDO; YM178; mirabegron; Betmiga

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics of mirabegron in plasma: Cmax

  Maximum concentration (Cmax)

  Days 1 - 7

• Pharmacokinetics of mirabegron in plasma: AUCinf

  Area under the curve from time zero to infinity (AUCinf)

  Days 1 - 7

• Pharmacokinetics of mirabegron in plasma: tmax

  The time after dosing when Cmax occurs (tmax)

  Days 1 - 7

• Pharmacokinetics of mirabegron in plasma: t1/2

  Apparent Terminal Elimination Half-life (t1/2)

  Days 1 - 7

Secondary Outcomes (3)

• Safety profile as assessed by adverse events, clinical laboratory evaluations, vital signs and electrocardiograms (ECG)

  Up to Day 7

• Safety as assessed by post-void residual volume (PVR)

  Day 1

• Acceptability and Palatability as assessed by taste and acceptance of the suspension (5-point scale)

  Day 1

Study Arms (1)

mirabegron

EXPERIMENTAL

single dose

Drug: mirabegron

Interventions

mirabegron DRUG

oral

Also known as: Myrbetriq, Myrbetric, Betanis, YM178, Betmiga

mirabegron

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is male or female from 3 to less than 12 years of age.
• Subject has a documented diagnosis according to the International Children's Continence Society (ICCS) criteria of:
• NDO, or
• Idiopathic OAB
• Subject's weight/height:
• Subject must have a body weight of ≥ 15.0 kg
• For NDO: subject is not suffering from malnutrition or is not grossly 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.
• Subject and subject's parent(s)/legal guardian agree that the subject will not participate in another interventional study while on treatment.
• Subject and subject's parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.
• Female subject must:
• Be of non-childbearing potential: Clearly pre-menarchal or in the judgment of the Investigator is pre-menarchal.

You may not qualify if:

• Subject has a known history of QTc prolongation or risk of QT prolongation (e.g. hypokalemia, family history of Long QT Syndrome) and/or QTcB of \> 460 ms.
• Subject has a (mean) resting pulse rate \> 99th percentile \[Fleming et al, 2011\].
• Subject has any clinically significant ECG (electrocardiogram) abnormality.
• Subject has established hypertension and a systolic or diastolic blood pressure greater than the 99th percentile of the normal range determined by sex, age and height, plus 5mmHg \[NIH 2005\].
• Subject has any clinically significant or unstable medical condition or disorder which, in the opinion of the Investigator, precludes the subject from participating in the study.
• Subject has current, untreated constipation (or fecal impaction for NDO subjects). If the constipation is being consistently treated for the last month, the subject can be included.
• Subject has been administered intradetrusor botulinum toxin injections; except if given \> 4 months prior to screening and symptoms reappeared comparable to those before botulinum toxin injections.
• Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN.
• Subject has severe renal impairment (estimated glomerular filtration rate \< 30 mL/min (Larsson)).
• Subject has any other clinically significant out of range results of urinalysis, biochemistry or hematology.
• Subject has a history or current diagnosis of any malignancy.
• Subject has known or suspected hypersensitivity to mirabegron, other ß3-agonists, any of the excipients used in the mirabegron oral suspension formulation or previous severe hypersensitivity to any drug.
• Subject meets any of the contra indications or precautions for use of mirabegron listed in the Investigator's Brochure (IB).
• Subject has used mirabegron within 12 days of the planned Reference Day (Day -4 to Day -1).
• Subject requires ongoing treatment with any of the following prohibited medications:

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (3)

Site DK45002

Aalborg, 9000, Denmark

Location

Site DK45001

Aarhus, 8200, Denmark

Location

Site PL48001

Warsaw, 04-730, Poland

Location

Related Links

• Link to results on the Astellas Clinical Study Results website.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 18, 2015
• Study Start: December 17, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); PL (1)