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

NCT01539707 | Completed Phase 1

• 2 other identifiers: 905-CL-0792011-000250-28
• Study Type: interventional
• Target: 14
• Locations: 7 countries
• Sites: 7

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.

Conditions

Overactive Bladder; Neurogenic Detrusor Overactivity

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Maximum concentration (Cmax)

  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 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

• 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

• 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

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

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

Study Arms (2)

AD-PED 5 mg

EXPERIMENTAL

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

Drug: Solifenacin succinate suspension 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

Interventions

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 dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

Also known as: YM905

AD-PED 5 mg; CH-PED 5 mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (7)

Site: 3201

Ghent, 9000, Belgium

Location

Unknown Facility

Québec, Quebec, G1V 4G2, Canada

Location

Site: 4501

Århus N, DK-8200, Denmark

Location

Site: 3102

Utrecht, 3584 EA, Netherlands

Location

Site: 4801

Warsaw, 04-730, Poland

Location

Site: 90

Ankara, 6100, Turkey (Türkiye)

Location

Site: 44

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

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 27, 2012
• Study Start: March 13, 2012
• Primary Completion: August 13, 2012
• Study Completion: August 13, 2012
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); GB (1); DK (1); CA (1); NL (1); TU (1); BE (1)