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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


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
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