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

Phase 1CompletedNCT01943487

Astellas Pharma Europe B.V.36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Drug-Drug Interaction (DDI)Healthy Subjects

Interventions

EC905DRUG

Oral

verapamilDRUG

Oral

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SGS Aster

Paris, France

Outcomes

Primary Outcomes

Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau

AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)

Time frame: Predose, Days 1, and 7-10

Pharmacokinetics of solifenacin in plasma: AUCtau

AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)

Time frame: Predose, Days 1, and 7-10

Pharmacokinetics of tamsulosin OCAS in plasma: Cmax

Cmax (maximum concentration)

Time frame: Predose, Days 1, and 7-10

Pharmacokinetics of solifenacin in plasma: Cmax

Cmax (maximum concentration)

Time frame: Predose, Days 1, and 7-10

Secondary Outcomes

Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil

Plasma: Ctrough (trough concentration), tmax (time to attain Cmax), CL/F (apparent total body clearance), PTR (peak trough ratio) Urine: AUCtau, Cmax, Ctrough, CL/F, tmax

Time frame: Predose, Days 27-30

Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil

AE (adverse events), clinical laboratory tests, vital signs, ECG, physical examination

Time frame: Screening to ESV (10 days after the last dosing)

Data from ClinicalTrials.gov

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