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

Healthy Subjects Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953887
• Other study ID #: 905-CL-072
• Secondary ID: 2009-015618-22
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2013
• Last updated: May 28, 2014
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: May 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• EC905
• Healthy Subjects
• Pharmacokinetics

Intervention

Drug:
• EC905
Oral
• solifenacin
oral
• tamsulosin
oral

Locations

Country	Name	City	State
United Kingdom	Parexel	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®	AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)	Predose to Day 10 after dosing (22 times)	No
Primary	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®	AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)	Predose to Day 10 after dosing (22 times)	No
Secondary	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®	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)	Predose to Day 10 after dosing (22 times)	No
Secondary	Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS®	Adverse events, clinical laboratory tests, vital signs, Electrocardiogram (ECG), physical examination	Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), or after withdrawal.)	No

External Links

•   Link to Results on JAPIC