The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children after taking a single oral dose.
- Conditions
- eurogenic Detrusor Overactivity (NDO)MedDRA version: 14.1Level: LLTClassification code 10012547Term: Detrusor hyperreflexiaSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2011-000250-28-DK
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
At screening:
1. Subject is male or female from 5 to less than 18 years of age.
2. Documented diagnosis of NDO, confirmed by urodynamics.
3. Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts.
4. Subject’s bowel function is being actively managed.
5. Able to swallow the study medication in accordance to the protocol.
6. 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.
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.
8. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). In the case of a minor, consent from a parent or guardian must be obtained. In the case of an adolescent, a written assent to participate may also be required per local IRB/IEC rules.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
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
At screening:
1. Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test.
2. 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.
3. Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years.
4. Subject has a QTcB interval greater than 440 ms, a history of QTc prolongation or at risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome [LQTS] as can be suspected in case of a family history or exercise induced syncope). QT interval greater than 470 ms at baseline.
5. Any clinically significant abnormality on ECG.
6. Any clinically significant or unstable medical condition or disorder which, in the opinion of the investigator, precludes the subject from participating in the study.
7. History or current diagnosis of any malignancy.
8. Diagnosis of central or X chromosome-linked diabetes insipidus.
9. Subject has a severe renal impairment (glomerular filtration rate < 30 ml/min).
10. 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.
11. Any other clinically significant out of range results of urinalysis, biochemistry or hematology.
12. 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.
13. 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.
14. 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).
15. 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.
16. 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.
17. Subject has a history of glaucoma
At Day 1:
1. 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.
2. Positive drug screen test for drugs of abuse at Day 1.
3. Positive alcohol breath test at Day 1.
4. 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.
5. Donation of blood or blood products within 3 months prior to Day 1.
6. Positive urine pregnancy test.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the pharmacokinetics of solifenacin succinate suspension after single-dose administration in children and adolescents with NDO.;Secondary Objective: To evaluate the safety and tolerability of solifenacin succinate suspension after single-dose administration in children and adolescents with NDO.;Primary end point(s): - Maximum concentration (C max)<br>- Time to attain C max (T max)<br>- Area under the plasma concentration – time curve (AUC) from time of dosing until last measurable concentration (AUC last) - only if non-compartmental approach is used to analyze the data<br>- AUC extrapolated until time is infinity (AUC inf)<br>- Apparent terminal elimination half-life (t 1/2)<br>- Apparent Total Body Clearance (CL/F) <br>- Apparent volume of distribution during the terminal phases (Vz/F)<br>;Timepoint(s) of evaluation of this end point: At each study visit (Day 1, Day 3, Day 5 and Day 7)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): AEs, clinical laboratory evaluations (hematology, biochemistry, urinalysis), vital signs, ECG and physical examination;Timepoint(s) of evaluation of this end point: At each study visit (Day 1, Day 3, Day 5 and Day 7)