NCT01953887

Brief Summary

A study to assess the amount of drug in the blood of young to middle aged, healthy, male subjects after they received the final formulation of EC905 compared to solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®). Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS® in 3 separate periods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

September 26, 2013

Last Update Submit

May 28, 2014

Conditions

EC905PharmacokineticsHealthy Subjects

Keywords

Phase IFinal formulation EC905Solifenacin succinateTamsulosin HClMarketed drugs

Outcome Measures

Primary Outcomes (2)

  • The Pharmacokinetics (PK) of solifenacin after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®

    AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)

    Predose to Day 10 after dosing (22 times)

  • The Pharmacokinetics (PK) of tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®

    AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)

    Predose to Day 10 after dosing (22 times)

Secondary Outcomes (2)

  • The PK of solifenacin and tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®

    Predose to Day 10 after dosing (22 times)

  • Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS®

    Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), or after withdrawal.)

Study Arms (3)

1 combination tablet EC905

EXPERIMENTAL
Drug: EC905

2: solifenacin

EXPERIMENTAL
Drug: solifenacin

3: tamsulosin

EXPERIMENTAL
Drug: tamsulosin

Interventions

EC905DRUG

Oral

1 combination tablet EC905
solifenacinDRUG

oral

Also known as: Vesicare®
2: solifenacin
tamsulosinDRUG

oral

Also known as: Omnic OCAS®
3: tamsulosin

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index between 18.5 and 30.0 kg/m2, inclusive

You may not qualify if:

  • Known or suspected hypersensitivity to solifenacin, tamsulosin, EC905, Vesicare, Omnic OCAS or any of the components of the formulations used.
  • Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.
  • Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

Solifenacin SuccinateTamsulosin

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

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

September 26, 2013

First Posted

October 1, 2013

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

GB(1)