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

Healthy Subjects Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943487
• Other study ID #: 905-CL-078
• Secondary ID: 2009-010841-29
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2013
• Last updated: May 29, 2014
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug-Drug Interaction (DDI)
• Healthy Subjects

Intervention

Drug:
• EC905
Oral
• verapamil
Oral

Locations

Country	Name	City	State
France	SGS Aster	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau	AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)	Predose, Days 1, and 7-10	No
Primary	Pharmacokinetics of solifenacin in plasma: AUCtau	AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)	Predose, Days 1, and 7-10	No
Primary	Pharmacokinetics of tamsulosin OCAS in plasma: Cmax	Cmax (maximum concentration)	Predose, Days 1, and 7-10	No
Primary	Pharmacokinetics of solifenacin in plasma: Cmax	Cmax (maximum concentration)	Predose, Days 1, and 7-10	No
Secondary	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	Predose, Days 27-30	No
Secondary	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	Screening to ESV (10 days after the last dosing)	No

External Links

•   Link to Results on JAPIC