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Neurogenic Detrusor OveractivityPhase 1NCT02211846

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

A Phase 1 study testing Mirabegron in people with Neurogenic Detrusor Overactivity and Overactive Bladder, run by Astellas Pharma Inc at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Mirabegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
13 sitesin 5 countries
Study dates
21 Sep 2014to 21 Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.
  • Female subjects must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the last study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
  • Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective form of contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continuing throughout the study period, and for 28 days after the final study drug administration.
  • Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after study drug administration.
  • 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

Who cannot join

  • 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.
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  • 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).
  • Any drugs that are sensitive CYP2D6 substrates with a narrow therapeutic index (such as thioridazine, flecainide, propafenone, imipramine, desipramine) and sensitive P-gp substrates (such as digoxin, dabigatran) within 5 half-lives prior to the planned reference day (Day -4 to Day -1).
  • Any moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers including natural and herbal remedies (such as itraconazole, rifampicin, phenytoin, carbamazepine, St. John's Wort, grapefruit, Seville orange) within 5 half-lives prior to the planned reference day (Day -4 to Day -1).
  • Subject has a positive urinary drug screen test for drugs of abuse.
  • Subject donated blood or blood products within 3 months prior to planned Day 1.
  • Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to the planned reference day (Day -4 to Day -1).
  • Subject's parent(s)/legal guardian is an employee of the Astellas Group, any Contract Research Organization (CRO) involved, or the Investigator site executing the study.
  • Subject has current, untreated constipation (or fecal impaction for NDO patients). 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 a positive urinary drug screen test for drugs of abuse.
  • Subject has a positive alcohol breath test.
  • Subject has used mirabegron in the past (last intake less than 24 days before planned reference day (Day -4 to Day -1).
  • Subject requires ongoing treatment with any of the following prohibited medications:
  • Any anticholinergics/antimuscarinics within 5 half-lives prior to intake of the reference day (Day -4 to Day -1).
  • Any drugs that are sensitive CYP2D6 substrates with a narrow therapeutic index (such as thioridazine, flecainide, propafenone, imipramine, desipramine) and sensitive P-gp substrates (such as digoxin, dabigatran) within 5 half-lives prior to the reference day (Day -4 to Day -1).
  • Any moderate or strong cytochrome CYP3A4/5 or P-gp inhibitors or inducers including natural and herbal remedies (such as itraconazole, rifampicin, phenytoin, carbamazepine, St. John's Wort) within 5 half-lives prior to reference day (Day -4 to Day -1).
  • Subject donated blood or blood products within 3 months prior to Day 1.
  • Subject (female subjects of childbearing potential) has a positive urinary pregnancy test.
  • Subject has a current symptomatic urinary tract infection.

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

Denmark5 sites

  • Site DK45003 Aalborg Sygehus Nord

    Aalborg, 9000

  • Site DK45001 Uni Hosp of Aarhus, Skejby

    Aarhus, 8200

  • Site DK45005 Rigshospitalet

    Copenhagen, 2100

  • Site DK45004 Børnelægen i Køge

    Koege, 4600

  • Site DK45002 Kolding Sygehus

    Kolding, 6000

Other trials in Denmark

Belgium4 sites

  • Site BE32009 Univ.Ziekenhuis Antwerpen

    Edegem, 2650

  • Site BE32003 Gent University Hospital

    Ghent, 9000

  • Site BE32004 AZ Groeninge, Campus Vercruyss

    Kortrijk, 8500

  • Site BE32011 U.Z. Leuven

    Leuven, 3000

Other trials in Belgium

Poland2 sites

  • Site PL48003 Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Site PL48001 Pomnik-Centrum Zdrowia Dziecka

    Warsaw, 04-730

Other trials in Poland

Norway1 site

  • Site NO47001 Haukeland Sykehus

    Bergen, 5021

Other trials in Norway

Serbia1 site

  • Site RS38010 Mother and Child Health Care

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: 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)

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.

Being tested
Mirabegron
Keywords
Pharmacokinetics, Mirabegron, Neurogenic detrusor overactivity (NDO), Overactive bladder (OAB)
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Also called Myrbetriq, Betmiga, Betanis

    oral

Study groups in NCT02211846
Study groupRoleWhat they receive
MirabegronExperimentalAdministered under fed and fasted conditions
Receives: Drug: Mirabegron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameter of mirabegron: Cmax

    Maximum concentration (Cmax)

    Measured: Day 1-7

  2. Pharmacokinetic parameter of mirabegron: tmax

    The time after dosing when Cmax occurs (tmax)

    Measured: Day 1-7

  3. Pharmacokinetic parameter of mirabegron: AUCinf

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

    Measured: Day 1-7

  4. Pharmacokinetic parameter of mirabegron: t1/2

    Apparent terminal elimination half-life (t1/2 )

    Measured: Day 1-7

Secondary outcomes (1)

  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)

    Measured: up to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study start21 Sep 2014
  3. Primary completion21 Sep 2015
  4. Study completion21 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211846
Sponsor's protocol ID
178-CL-202
Other IDs
2014-000340-15, 2014
Status last verified
Oct 2024
First submitted
6 Aug 2014
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirabegron in people with Neurogenic Detrusor Overactivity and Overactive Bladder, run by Astellas Pharma Inc at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Denmark, Belgium, Poland, Norway, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameter of mirabegron: Cmax (time frame: Day 1-7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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