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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

NCT ID: NCT02010944

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Phase 1 Bioavailability Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1: FDC-SET-SET

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

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

oral

mirabegron

Intervention Type DRUG

oral

mirabegron/solifenacin succinate

Intervention Type DRUG

oral

2: SET-FDC-FDC

Single Entity Tablets followed by two periods of Fixed Dose Combination

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

oral

mirabegron

Intervention Type DRUG

oral

mirabegron/solifenacin succinate

Intervention Type DRUG

oral

Interventions

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solifenacin succinate

oral

Intervention Type DRUG

mirabegron

oral

Intervention Type DRUG

mirabegron/solifenacin succinate

oral

Intervention Type DRUG

Other Intervention Names

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Vesicare®, YM905 YM178 YM178/YM905

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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Parexel

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002650-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-103

Identifier Type: -

Identifier Source: org_study_id

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