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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01539707
First received: February 7, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Neurogenic Detrusor Overactivity
Drug: Solifenacin succinate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The assessment of pharmacokinetics profile of solifenacin succinate suspension after single-dose administration, measured by plasma concentration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    • Maximum concentration (Cmax)
    • Time to attain Cmax (tmax)
    • Area under the plasma concentration - time curve (AUC) from time of dosing until last measurable concentration (AUClast)
    • AUC extrapolated until time is infinity (AUCinf)
    • Apparent terminal elimination half-life (t1/2)
    • Apparent Total Body Clearance (CL/F)
    • Apparent volume of distribution during the terminal phases (Vz/F)


Secondary Outcome Measures:
  • The assessment of safety of solifenacin succinate suspension after single-dose administration, assessed by adverse events, laboratory evaluations, vital signs, ECG and physical examination [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1
open label, solifenacin succinate suspension
Drug: Solifenacin succinate
oral suspension
Other Name: YM905

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539707

Locations
Belgium
Site: 3201
Gent, Belgium, 9000
Canada, Quebec
Québec City, Quebec, Canada, G1V 4G2
Denmark
Site: 4501
Århus N, Denmark, DK-8200
Netherlands
Site: 3102
Utrecht, Netherlands, 3584 EA
Poland
Site: 4801
Warszawa, Poland, 04-730
Turkey
Site: 90
Ankara, Turkey, 6100
United Kingdom
Site: 44
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01539707     History of Changes
Other Study ID Numbers: 905-CL-079, 2011-000250-28
Study First Received: February 7, 2012
Last Updated: October 29, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Denmark: Danish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Neurogenic Detrusor Overactivity
Solifenacin succinate suspension
Pharmacokinetics
Phase 1

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014