A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin

Sponsor

Astellas Pharma Europe B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT01953887

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to assess the amount of drug in the blood of young to middle aged, healthy, male subjects after they received the final formulation of EC905 compared to solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).

Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS® in 3 separate periods.

Condition or Disease	Intervention/Treatment	Phase
EC905 Pharmacokinetics Healthy Subjects	Drug: EC905 Drug: solifenacin Drug: tamsulosin	Phase 1

Detailed Description

The subjects are randomized to one of 6 treatment sequence groups.

Subjects are admitted to the clinical unit on Day -1 for pre-dose assessments. They remain in the clinic for two periods of 11 days and one period of 14 days.

After randomization the subjects receive a single dose treatment on Day 1 followed by blood sampling for pharmacokinetic (PK) assessment. For both EC905 and Vesicare®, blood sampling continues for 10 days after dosing; for Omnic OCAS®, it continues for 3 days after dosing.

Each period is separated by a wash-out period of at least 4 day, and subjects are checked for eligibility again one day prior to the start of a new dosing day.

Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.

A blood sample is drawn for CYP2D6 genotyping, in order to evaluate the effect of the CYP2D6 genotype on the PK of tamsulosin.

Subjects return for an End of Study Visit (ESV) 7 days after the last on-site period, or after withdrawal.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®)

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 combination tablet EC905	Drug: EC905 Oral
Experimental: 2: solifenacin	Drug: solifenacin oral Other Names: Vesicare®
Experimental: 3: tamsulosin	Drug: tamsulosin oral Other Names: Omnic OCAS®

Arm

Intervention/Treatment

Experimental: 1 combination tablet EC905

Drug: EC905

Oral

Experimental: 2: solifenacin

Drug: solifenacin

oral

Other Names:

Vesicare®

Experimental: 3: tamsulosin

Drug: tamsulosin

oral

Other Names:

Omnic OCAS®

Outcome Measures

Primary Outcome Measures

The Pharmacokinetics (PK) of solifenacin after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS® [Predose to Day 10 after dosing (22 times)]
AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)
The Pharmacokinetics (PK) of tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS® [Predose to Day 10 after dosing (22 times)]
AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)

Secondary Outcome Measures

The PK of solifenacin and tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS® [Predose to Day 10 after dosing (22 times)]
AUCinf (AUC extrapolated until infinity), t1/2 (Apparent terminal elimination half-life), tmax (Time to attain Cmax), CL/F (Apparent total body plasma clearance), Vz/F (Apparent volume of distribution)
Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS® [Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), or after withdrawal.)]
Adverse events, clinical laboratory tests, vital signs, Electrocardiogram (ECG), physical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body Mass Index between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

Known or suspected hypersensitivity to solifenacin, tamsulosin, EC905, Vesicare, Omnic OCAS or any of the components of the formulations used.
Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.
Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2