A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder

NCT02211846 | Completed Phase 1

• 2 other identifiers: 178-CL-2022014-000340-15
• Study Type: interventional
• Target: 34
• Locations: 5 countries
• Sites: 13

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.

Conditions

Neurogenic Detrusor Overactivity; Overactive Bladder; Pharmacokinetics of Mirabegron

Keywords

Pharmacokinetics; Mirabegron; Neurogenic detrusor overactivity (NDO); Overactive bladder (OAB)

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameter of mirabegron: Cmax

  Maximum concentration (Cmax)

  Day 1-7

• Pharmacokinetic parameter of mirabegron: tmax

  The time after dosing when Cmax occurs (tmax)

  Day 1-7

• Pharmacokinetic parameter of mirabegron: AUCinf

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

  Day 1-7

• Pharmacokinetic parameter of mirabegron: t1/2

  Apparent terminal elimination half-life (t1/2 )

  Day 1-7

Secondary Outcomes (1)

• 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

Study Arms (1)

Mirabegron

EXPERIMENTAL

Administered under fed and fasted conditions

Drug: Mirabegron

Interventions

Mirabegron DRUG

oral

Also known as: Myrbetriq, Betmiga, Betanis

Mirabegron

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Clearly pre-menarchal or in the judgment of the Investigator is pre-menarchal
• Documented surgically sterile.
• Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
• And have a negative urine pregnancy test pre-dose Day 1,
• And, if heterosexually active agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.

You may not qualify if:

• Subject is pregnant.
• Subject has a known history of QTc prolongation or risk of QT prolongation (e.g. hypokalemia, family history of Long QT Syndrome).
• Subject has an abnormal (mean) pulse rate according to the ranges specified below: age 5 to less than 8 years: \< 60 bpm or \> 110 bpm; age 8 to less than 12 years: \< 55 bpm or \> 100 bpm; age 12 to less than 18 years: \< 50 bpm or \> 100 bpm.
• Subject has any clinically significant ECG abnormality.
• Subject has mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg \[National Institute of Health, 2005\].
• 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 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 2 times the upper limit of normal (ULN) or total bilirubin greater than or equal to 1.5 times the ULN.
• Subject has severe renal impairment (estimated glomerular filtration rate (MDRD) \< 30 mL/min).
• 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 OCAS tablet formulation or previous severe hypersensitivity to any drug.
• Subject meets any of the contra-indications or precautions for use of mirabegron as mentioned in the Investigator's Brochure (IB).
• Subject has used mirabegron in the past (last intake less than 12 days before planned reference day (Day -4 to Day -1).
• Subject requires ongoing treatment with any of the following prohibited medications:
• Any anticholinergic/antimuscarinic drugs within 5 half-lives prior to planned reference day (Day -4 to Day -1).

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Europe B.V.: collaborator

Study Sites (13)

Site BE32009 Univ.Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Site BE32003 Gent University Hospital

Ghent, 9000, Belgium

Location

Site BE32004 AZ Groeninge, Campus Vercruyss

Kortrijk, 8500, Belgium

Location

Site BE32011 U.Z. Leuven

Leuven, 3000, Belgium

Location

Site DK45003 Aalborg Sygehus Nord

Aalborg, 9000, Denmark

Location

Site DK45001 Uni Hosp of Aarhus, Skejby

Aarhus, 8200, Denmark

Location

Site DK45005 Rigshospitalet

Copenhagen, 2100, Denmark

Location

Site DK45004 Børnelægen i Køge

Koege, 4600, Denmark

Location

Site DK45002 Kolding Sygehus

Kolding, 6000, Denmark

Location

Site NO47001 Haukeland Sykehus

Bergen, 5021, Norway

Location

Site PL48003 Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Site PL48001 Pomnik-Centrum Zdrowia Dziecka

Warsaw, 04-730, Poland

Location

Site RS38010 Mother and Child Health Care

Belgrade, 11000, Serbia

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

• Clinical Research Physician

  Astellas Global Development

  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 6, 2014
• First Posted: August 8, 2014
• Study Start: September 21, 2014
• Primary Completion: September 21, 2015
• Study Completion: September 21, 2015
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); NO (1); BE (4); DK (5); SE (1)