EUCTR2014-000340-15-DE进行中（未招募）不适用
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)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
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-neurogenic detrusor overactivity (NDO) -overactive bladder (OAB)MedDRA version: 17.0Level: LLTClassification code 10012547Term: Detrusor hyperreflexiaSystem Organ Class: 100000004857MedDRA version: 17.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857EUCTR2014-000340-15-BEAstellas Pharma Europe B.V.30
进行中（未招募）
不适用
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-neurogenic detrusor overactivity (NDO) -overactive bladder (OAB)MedDRA version: 18.0Level: LLTClassification code 10012547Term: Detrusor hyperreflexiaSystem Organ Class: 100000004857MedDRA version: 18.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857EUCTR2014-000340-15-DKAstellas Pharma Europe B.V.42
进行中（未招募）
1 期
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 bladderEUCTR2014-000340-15-NOAstellas Pharma Europe B.V.34
进行中（未招募）
1 期
A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB) Protocol for Phase I Study of solifenacin succinate suspension Single ascending dose PK study - GIRAFFEOveractive bladderMedDRA version: 12.1 Level: LLT Classification code 10059617 Term: Overactive bladderEUCTR2009-017197-21-GBAstellas Pharma Europe B.V.42
进行中（未招募）
不适用
A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB)Protocol for Phase I Study of solifenacin succinate suspensionSingle ascending dose PK study - GIRAFFEOveractive bladderMedDRA version: 12.1Level: LLTClassification code 10059617Term: Overactive bladderEUCTR2009-017197-21-NOAstellas Pharma Europe B.V.36