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Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Primary Purpose

Overactive Bladder, Neurogenic Detrusor Overactivity

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Solifenacin succinate suspension 5 mg

About this trial

This is an interventional other trial for Overactive Bladder focused on measuring Solifenacin succinate suspension, Pharmacokinetics, Phase 1, Neurogenic Detrusor Overactivity

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

At Day 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
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.

Sites / Locations

Site: 3201
Site: 4501
Site: 3102
Site: 4801
Site: 90
Site: 44

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AD-PED 5 mg

CH-PED 5 mg

Arm Description

Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.

Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate.

Outcomes

Primary Outcome Measures

Maximum concentration (Cmax)

Time to Attain Cmax (tmax)

Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)

Apparent Terminal Elimination Half-life (t1/2)

Apparent Total Body Clearance (CL/F)

Apparent Volume of Distribution During the Terminal Phase (Vz/F)

Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs)

Safety is monitored by collecting AEs, which includes abnormal laboratory tests, vital signs or ECG data that are defined as an AE if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study medication or is clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) is defined as an AE that occurs or worsens after study drug administration. A serious AE (SAE) is any untoward medical occurrence that, at any dose: Results in death, is life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events.

Full Information

NCT ID

NCT01539707

First Posted

February 7, 2012

Last Updated

October 26, 2018

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01539707

Brief Title

Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

March 13, 2012 (Actual)

Primary Completion Date

August 13, 2012 (Actual)

Study Completion Date

August 13, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Neurogenic Detrusor Overactivity

Keywords

Solifenacin succinate suspension, Pharmacokinetics, Phase 1, Neurogenic Detrusor Overactivity

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AD-PED 5 mg

Arm Type

Experimental

Arm Description

Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.

Arm Title

CH-PED 5 mg

Arm Type

Experimental

Arm Description

Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate.

Intervention Type

Drug

Intervention Name(s)

Solifenacin succinate suspension 5 mg

Other Intervention Name(s)

YM905

Intervention Description

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

Primary Outcome Measure Information:

Title

Maximum concentration (Cmax)

Time Frame