A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Phase 1; Bioavailability

Treatments: Drug: solifenacin succinate; Drug: mirabegron; Drug: mirabegron/solifenacin succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02010944

178-CL-103

2012-002650-23 (EudraCT Number)

Details and patient eligibility

About

This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.

Full description

There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.

The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.

Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.

Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.

An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subject must agree to not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.
• Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.

Exclusion criteria

• Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.
• Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.
• The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.
• Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1: FDC-SET-SET

Experimental group

Description:

Fixed Dose Combination followed by two periods of the Single Entity Tablets

Treatment:

Drug: mirabegron/solifenacin succinate

Drug: mirabegron

Drug: solifenacin succinate

2: SET-FDC-FDC

Experimental group

Description:

Single Entity Tablets followed by two periods of Fixed Dose Combination

Treatment:

Drug: mirabegron/solifenacin succinate

Drug: mirabegron

Drug: solifenacin succinate