NCT02010944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
Last Updated

December 13, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 4, 2013

Last Update Submit

December 10, 2013

Conditions

Phase 1BioavailabilityHealthy Subjects

Keywords

SolifenacinMirabegronFixed-dose combination (FDC)Single Entity Tablet (SET)PharmacokineticsBioavailability

Outcome Measures

Primary Outcomes (6)

  • Pharmacokinetic parameter of solifenacin in plasma as measured by Cmax (Maximum concentration)

    Days 1-11

  • Pharmacokinetic parameter of solifenacin in plasma as measured by AUClast (AUC until last sample taken)

    Days 1-11

  • Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity)

    Days 1-11

  • Pharmacokinetic parameter of mirabegron in plasma as measured by Cmax (Maximum concentration)

    Days 1-11

  • Pharmacokinetic parameter of mirabegron in plasma as measured by AUClast (AUC until last sample taken)

    Days 1-11

  • Pharmacokinetic parameter of mirabegron in plasma as measured by AUCinf (AUC extrapolated until infinity)

    Days 1-11

Secondary Outcomes (3)

  • Pharmacokinetic profile of Solifenacin in plasma

    Days 1-11

  • Pharmacokinetic profile of mirabegron in plasma

    Days 1-11

  • Safety and tolerability of solifenacin succinate and mirabegron assessed by adverse events, vital signs, laboratory tests, physical examination and 12-lead electrocardiogram (ECG)

    Screening to End of Study Visit (Day 11 Period 3 or within 7 to 14 days after discontinuation)

Study Arms (2)

1: FDC-SET-SET

EXPERIMENTAL

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

Drug: solifenacin succinateDrug: mirabegronDrug: mirabegron/solifenacin succinate

2: SET-FDC-FDC

EXPERIMENTAL

Single Entity Tablets followed by two periods of Fixed Dose Combination

Drug: solifenacin succinateDrug: mirabegronDrug: mirabegron/solifenacin succinate

Interventions

solifenacin succinateDRUG

oral

Also known as: Vesicare®,, YM905
1: FDC-SET-SET2: SET-FDC-FDC
mirabegronDRUG

oral

Also known as: YM178
1: FDC-SET-SET2: SET-FDC-FDC
mirabegron/solifenacin succinateDRUG

oral

Also known as: YM178/YM905
1: FDC-SET-SET2: SET-FDC-FDC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

Solifenacin Succinatemirabegron

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Study Manager

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2013

First Posted

December 13, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 13, 2013

Record last verified: 2013-10

Locations

DE(1)