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A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet

NCT ID: NCT01943487

Last Updated: 2014-05-30

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

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This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.

Detailed Description

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The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.

Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.

Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.

On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.

Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.

Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.

Conditions

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Drug-Drug Interaction (DDI) Healthy Subjects

Keywords

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Phase I Verapamil Tamsulosin OCAS Solifenacin Pharmacokinetics EC905

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1: verapamil + EC905

Group Type EXPERIMENTAL

EC905

Intervention Type DRUG

Oral

verapamil

Intervention Type DRUG

Oral

Interventions

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EC905

Oral

Intervention Type DRUG

verapamil

Oral

Intervention Type DRUG

Other Intervention Names

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tamsulosin OCAS and solifenacin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known or suspected hypersensitivity to EC905 or any of the components of the formulation used
* Known or suspected hypersensitivity to verapamil or any of the components of the formulation used
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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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Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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SGS Aster

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-010841-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

905-CL-078

Identifier Type: -

Identifier Source: org_study_id