A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Apparent Terminal Elimination Half-life (t1/2)
研究概览
简要总结
The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of NDO, confirmed by urodynamics
- •Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts
- •Subject's bowel function is being actively managed
- •Able to swallow the study medication in accordance to the protocol
- •Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study 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
排除标准
- •At screening:
- •Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test
- •Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention
- •Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years
- •History of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome [LQTS]). QT interval greater than 470 ms at baseline
- •Any clinically significant abnormality on ECG
- •History or current diagnosis of any malignancy
- •Diagnosis of central or X chromosome-linked diabetes insipidus
- •Cystatine C is greater than or equal to 2 times the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN
- •Any other clinically significant out of range results of urinalysis, biochemistry or hematology
- •Known or suspected hypersensitivity to solifenacin (or other anticholinergics), any of the excipients used in the current formulation or previous severe hypersensitivity to any drug
- •Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug whichever is longer) prior to Day 1
- •Requires ongoing treatment with any of the following prohibited medications: antimuscarinic therapy, tricyclic/tetracyclic antidepressants, H1 antihistamines, strong CYP3A4 inhibitors, strong CYP3A4 inducers (many antiepileptic drugs like carbamazepine, phenytoin and phenobarbital)
- •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], judged as clinically significant by the investigator
- •Subject's parent(s)/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study
- •Consumption of grapefruit and products made of it (e.g., juice), and Seville oranges and products made of it (e.g., marmalade) within 14 days prior to Day 1
- •Positive drug screen test for drugs of abuse at Day 1
- •Positive alcohol breath test at Day 1
- •Use of prohibited prior and concomitant medication:
- •Antimuscarinics, tricyclic/tetracyclic antidepressants, H1
- •antihistamines within 5 half-lives prior to intake of study drug at Day 1
- •Prescribed or over the counter (OTC) drugs that are potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), CYP3A4 substrates with higher affinity (e.g., verapamil, diltiazem), or potent CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine), including natural and herbal remedies (e.g., St. John's Wort) within 14 days prior to intake of study drug at Day 1
- •Donation of blood or blood products within 3 months prior to Day 1.
研究组 & 干预措施
AD-PED 5 mg
Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.
干预措施: Solifenacin succinate suspension 5 mg (Drug)
CH-PED 5 mg
Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate.
干预措施: Solifenacin succinate suspension 5 mg (Drug)
结局指标
主要结局
Apparent Terminal Elimination Half-life (t1/2)
时间窗: Day 1 predose up to Day 7 postdose
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
时间窗: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
时间窗: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
时间窗: Day 1 predose up to Day 7 postdose
Maximum concentration (Cmax)
时间窗: Day 1 predose up to Day 7 postdose
Time to Attain Cmax (tmax)
时间窗: Day 1 predose up to Day 7 postdose
Apparent Total Body Clearance (CL/F)
时间窗: Day 1 predose up to Day 7 postdose
次要结局
- Number of Participants with Adverse Events (AEs)(From the first dose of study drug up to 7 days postdose)