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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Drug-Drug Interaction (DDI)

Treatments

Drug: EC905

Drug: verapamil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943487

905-CL-078

2009-010841-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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