Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

October 26, 2018 updated by: Astellas Pharma Inc

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)

This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

Study Overview

Detailed Description

This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.

The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
      • Kortrijk, Belgium, 8500
      • Arhus, Denmark, 8200
      • Goteborg, Sweden, 41685
      • Uppsala, Sweden, 75185
      • Cambridge, United Kingdom, CB2 2QQ
      • Manchester, United Kingdom, M13 9WL
      • Sheffield, United Kingdom, S10 2TH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
  • Daytime urgency incontinence at least once/day

Exclusion Criteria:

  • Daytime voiding frequency less than 5
  • Uroflow indicative of pathology other than OAB
  • Maximum voided volume > age expected capacity ([age +1] x 30) in ml
  • Post voiding residual (PVR) > 10% of the functional bladder capacity
  • Monosymptomatic enuresis
  • Congenital anomalies of the genito-urinary tract or nervous system
  • Current constipation (when treated the patient can enter the study)
  • Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
  • Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-PED 2.5 mg
Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate.
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 doses of 2.5 mg of solifenacin once daily in adults.
Other Names:
  • YM905
Experimental: AD-PED 5 mg
Male and female adolescents aged 12 to less than 18 years old who receive PED of 5 mg of solifenacin succinate.
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 doses of 5 mg dose of solifenacin once daily in adults.
Other Names:
  • YM905
Experimental: AD-PED 10 mg
Male and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate.
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 doses 10 mg dose of solifenacin once daily in adults.
Other Names:
  • YM905
Experimental: CH-PED 2.5 mg
Male and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate.
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 doses of 2.5 mg of solifenacin once daily in adults.
Other Names:
  • YM905
Experimental: 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.
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 doses of 5 mg dose of solifenacin once daily in adults.
Other Names:
  • YM905
Experimental: CH-PED 10 mg
Male and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate.
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 doses 10 mg dose of solifenacin once daily in adults.
Other Names:
  • YM905

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Concentration (Cmax)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose
Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose
Time to Attain Cmax (tmax)
Time Frame: Day 1 predose up to Day 7 postdose
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)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose
Apparent Total Body Clearance (CL/F)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time Frame: Day 1 predose up to Day 7 postdose
Day 1 predose up to Day 7 postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: From the first dose of study drug up to 7 days postdose
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.
From the first dose of study drug up to 7 days postdose
Change from baseline in postvoid residual (PVR) volume
Time Frame: Baseline (screening) and 4 hours postdose
PVR volume is assessed by ultrasonography or bladder scan.
Baseline (screening) and 4 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2010

Primary Completion (Actual)

August 14, 2011

Study Completion (Actual)

August 14, 2011

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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