Clinical trial NCT01943487: A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet
Official title: A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-Drug Interaction (DDI)
Healthy Subjects
Keywords: Phase I
Verapamil
Tamsulosin OCAS
Solifenacin
Pharmacokinetics
EC905
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
timeFrame: Predose, Days 1, and 7-10
measure: Pharmacokinetics of solifenacin in plasma: AUCtau
timeFrame: Predose, Days 1, and 7-10
measure: Pharmacokinetics of tamsulosin OCAS in plasma: Cmax
timeFrame: Predose, Days 1, and 7-10
measure: Pharmacokinetics of solifenacin in plasma: Cmax
timeFrame: Predose, Days 1, and 7-10
Secondary outcomes:
measure: Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil
timeFrame: Predose, Days 27-30
measure: Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil
timeFrame: Screening to ESV (10 days after the last dosing)
Other outcomes:
Locations:
city: Paris
country: France
facility: SGS Aster
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: