Overactive BladderPhase 1NCT02526979
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)
A Phase 1 study testing mirabegron in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Astellas Pharma Europe B.V. at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Overactive Bladder, Neurogenic Detrusor Overactivity
- 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
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Dec 2015to 30 Sep 2016
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
- Or the following inclusion criteria are to be followed, if applicable (rare cases): Female subject that reached puberty must: 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 predose Day 1, And, if heterosexually active agree to consistently use 2 forms of highly effective form of birth control starting at screening and throughout the study period and for28 days after the final study drug administration.
Who cannot join
- 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.
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- 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:
- 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 4 weeks (inducers only) or 5 half-lives (inhibitors only) prior to the planned Reference Day (Day -4 to 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Multicentre, Open-Label, Single Dose, Phase 1 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)
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.
- Being tested
- mirabegron
- Keywords
- OAB, overactive bladder, Myrbetric, neurogenic detrusor overactivity, Betanis, Myrbetriq, NDO, YM178, mirabegron, Betmiga
- 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, Myrbetric, Betanis, YM178
oral
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Experimental | single dose Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of mirabegron in plasma: Cmax
Maximum concentration (Cmax)
Measured: Days 1 - 7
Pharmacokinetics of mirabegron in plasma: AUCinf
Area under the curve from time zero to infinity (AUCinf)
Measured: Days 1 - 7
Pharmacokinetics of mirabegron in plasma: tmax
The time after dosing when Cmax occurs (tmax)
Measured: Days 1 - 7
Pharmacokinetics of mirabegron in plasma: t1/2
Apparent Terminal Elimination Half-life (t1/2)
Measured: Days 1 - 7
Secondary outcomes (3)
Safety profile as assessed by adverse events, clinical laboratory evaluations, vital signs and electrocardiograms (ECG)
Clinical laboratory evaluations include hematology, biochemistry and urinalysis.
Measured: Up to Day 7
Safety as assessed by post-void residual volume (PVR)
Measured: Day 1
Acceptability and Palatability as assessed by taste and acceptance of the suspension (5-point scale)
5-point scale consists of 3 questions ranging in score from 0=Really Bad to 4=Really Good.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start17 Dec 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526979
- Sponsor's protocol ID
- 178-CL-203
- Other IDs
- 2015-000700-26, 2015
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2015
- Last updated
- 31 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-Label, Single Dose, Phase 1 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)
- ClinicalTrials.gov ID
- NCT02526979
- Acronym / sponsor ID
- 178-CL-203
- Keywords
- OAB, overactive bladder, Myrbetric, neurogenic detrusor overactivity, Betanis, Myrbetriq, NDO, YM178
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirabegron | Experimental | Drug: mirabegronsingle dose |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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:
- Subject's weight/height:
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegronAlso: Myrbetriq, Myrbetric, Betanis, YM178oral | Drug | mirabegron |
Primary outcome
Pharmacokinetics of mirabegron in plasma: Cmax
Time frame: Days 1 - 7
Maximum concentration (Cmax)
Pharmacokinetics of mirabegron in plasma: AUCinf
Time frame: Days 1 - 7
Area under the curve from time zero to infinity (AUCinf)
Pharmacokinetics of mirabegron in plasma: tmax
Time frame: Days 1 - 7
The time after dosing when Cmax occurs (tmax)
Pharmacokinetics of mirabegron in plasma: t1/2
Time frame: Days 1 - 7
Apparent Terminal Elimination Half-life (t1/2)
3 secondary outcomes
Safety profile as assessed by adverse events, clinical laboratory evaluations, vital signs and electrocardiograms (ECG)
Time frame: Up to Day 7
Safety as assessed by post-void residual volume (PVR)
Time frame: Day 1
Acceptability and Palatability as assessed by taste and acceptance of the suspension (5-point scale)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Europe B.V.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mirabegron in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Astellas Pharma Europe B.V. at 3 sites in 2 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 14 inclusion and 20 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 31 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 3 sites in Denmark, Poland. 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?
Pharmacokinetics of mirabegron in plasma: Cmax (time frame: Days 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?
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 31 Oct 2024.