This is a short study, performed in different countries, to investigate how well one dose of mirabegron in tablet form is taken up, how long it stays in the body and how well it will be tolerated in children/adolescents aged 5 to less than 18 years with symptoms of neurogenic detrusor overactivity or overactive bladder

Conditions: -neurogenic detrusor overactivity (NDO) -overactive bladder (OAB)
MedDRA version: 16.1Level: LLTClassification code 10012547Term: Detrusor hyperreflexiaSystem Organ Class: 100000004857
MedDRA version: 16.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857
Therapeutic area: Body processes [G] - Biological Phenomena [G16]

Registration Number: EUCTR2014-000340-15-DE

Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject and/or from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent by the subject is given as required by local law.
2. Subject is male or female from 5 to less than 18 years of age.
3. Subject has a documented diagnosis of:
- Neurogenic detrusor overactivity (NDO), or
- Idiopathic overactive bladder (OAB) according to International Children’s Continence Society (ICCS) criteria.
4. 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
5. Subject is able to swallow the study medication in accordance with the protocol.
6. Subject and subject’s parent(s)/legal guardian agree that the subject will not participate in another interventional study while on treatment.
7. Subject and subject’s parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject is pregnant.
2. Subject has a known history of QTc prolongation or risk of QT prolongation (e.g. hypokalemia, family history of Long QT Syndrome).
3. 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.
4. Subject has any clinically significant ECG abnormality.
5. 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]
6. Subject has severe renal impairment (estimated glomerular filtration rate (MDRD) < 30 mL/min).
7. Subject has any other clinically significant out of range results of urinalysis, biochemistry or hematology.
8. Subject has a history or current diagnosis of any malignancy.
9. 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.
10. Subject has used mirabegron in the past (last intake less than 24 days before planned reference day (Day -4 to Day -1).
11. 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).
12. Subject has a positive urinary drug screen test for drugs of abuse.
13. 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.