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

Astellas

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Solifenacin succinate suspension 10 mg; Drug: Solifenacin succinate suspension 5 mg; Drug: Solifenacin succinate suspension 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262391

2009-017197-21 (EudraCT Number)

905-CL-075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 6 patient groups

AD-PED 2.5 mg

Experimental group

Description:

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.

Treatment:

Drug: Solifenacin succinate suspension 2.5 mg

AD-PED 5 mg

Experimental group

Description:

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

Treatment:

Drug: Solifenacin succinate suspension 5 mg

AD-PED 10 mg

Experimental group

Description:

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

Treatment:

Drug: Solifenacin succinate suspension 10 mg

CH-PED 2.5 mg

Experimental group

Description:

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

Treatment:

Drug: Solifenacin succinate suspension 2.5 mg

CH-PED 5 mg

Experimental group

Description:

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

Treatment:

Drug: Solifenacin succinate suspension 5 mg

CH-PED 10 mg

Experimental group

Description:

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

Treatment:

Drug: Solifenacin succinate suspension 10 mg