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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 VesicareĀ®, blood sampling continues for 10 days after dosing; for Omnic OCASĀ®, 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


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
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