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

NCT01262391 | Completed Phase 1

• 2 other identifiers: 905-CL-0752009-017197-21
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 8

Brief Summary

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.

Conditions

Urinary Bladder, Overactive

Keywords

Overactive bladder; Solifenacin suspension; Pharmacokinetics; Single-dose; Pediatric

Outcome Measures

Primary Outcomes (7)

• Maximum Concentration (Cmax)

  Day 1 predose up to Day 7 postdose

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

  Day 1 predose up to Day 7 postdose

• Apparent Terminal Elimination Half-life (t1/2)

  Day 1 predose up to Day 7 postdose

• Time to Attain Cmax (tmax)

  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)

  Day 1 predose up to Day 7 postdose

• Apparent Total Body Clearance (CL/F)

  Day 1 predose up to Day 7 postdose

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

  Day 1 predose up to Day 7 postdose

Secondary Outcomes (2)

• Number of Participants with Adverse Events (AEs)

  From the first dose of study drug up to 7 days postdose

• Change from baseline in postvoid residual (PVR) volume

  Baseline (screening) and 4 hours postdose

Study Arms (6)

AD-PED 2.5 mg

EXPERIMENTAL

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.

Drug: Solifenacin succinate suspension 2.5 mg

AD-PED 5 mg

EXPERIMENTAL

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

Drug: Solifenacin succinate suspension 5 mg

AD-PED 10 mg

EXPERIMENTAL

Male and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate.

Drug: Solifenacin succinate suspension 10 mg

CH-PED 2.5 mg

EXPERIMENTAL

Male and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate.

Drug: Solifenacin succinate suspension 2.5 mg

CH-PED 5 mg

EXPERIMENTAL

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

Drug: Solifenacin succinate suspension 5 mg

CH-PED 10 mg

EXPERIMENTAL

Male and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate.

Drug: Solifenacin succinate suspension 10 mg

Interventions

Solifenacin succinate suspension 2.5 mg DRUG

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.

Also known as: YM905

AD-PED 2.5 mg; CH-PED 2.5 mg

Solifenacin succinate suspension 5 mg DRUG

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.

Also known as: YM905

AD-PED 5 mg; CH-PED 5 mg

Solifenacin succinate suspension 10 mg DRUG

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.

Also known as: YM905

AD-PED 10 mg; CH-PED 10 mg

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (8)

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Kortrijk, 8500, Belgium

Location

Unknown Facility

Aarhus, 8200, Denmark

Location

Unknown Facility

Gothenburg, 41685, Sweden

Location

Unknown Facility

Uppsala, 75185, Sweden

Location

Unknown Facility

Cambridge, CB2 2QQ, United Kingdom

Location

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

Unknown Facility

Sheffield, S10 2TH, United Kingdom

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: December 17, 2010
• Study Start: October 20, 2010
• Primary Completion: August 14, 2011
• Study Completion: August 14, 2011
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); SE (2); DK (1); BE (2)