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

Healthy Subjects Clinical Trial

Official title:

An Open-label, Single Dose, Randomized, Three-way Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics of Solifenacin and Tamsulosin Administered as Combination Tablet EC905 in Young, Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953861
• Other study ID #: 905-CL-054
• Secondary ID: 2009-013419-36
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2013
• Last updated: May 28, 2014
• Start date: April 2010
• Est. completion date: June 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

To evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet EC905. Also to evaluate the safety and tolerability of single doses of EC905 in young, healthy male subjects, when administered under fed (low and high fat) or fasting conditions.

Description:

Subjects are admitted to the clinic on Day -1 and receive a single dose of the combination tablet EC905 on the first day of 3 periods, under three conditions (high fat breakfast, low fat breakfast, and fasting) in order to evaluate the effect of food.

Blood sampling for pharmacokinetic (PK) assessment is performed on the dosing day and for 11 days after dosing in each period. This 11-day on-site period is repeated three times so that all subjects are dosed under all conditions. Each period is separated by 7 days off site.

Subjects return for an End of Study Visit (ESV) at least 7 days after the last 11 day on-site period, or after withdrawal.

On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the effect of food on the PK of solifenacin and tamsulosin HCl. The aim is to show the absence of a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food effect after a high fat breakfast vs. fasting conditions.

Subjects are randomized to one of 6 possible sequences of fasted or fed conditions.

Screening takes place from Day -21 to Day -1. They are admitted to the clinic on Day -1. Blood sampling for PK assessment is performed from Day 1 to Day 11 of each period. This 11 day on-site period is repeated three times in order to allow all subjects to be dosed under fed (low and high fat) and fasting conditions.

The 11 day on-site periods are separated by 7-day off site periods; subjects are checked for eligibility again one day prior to the start of a new dosing day.

Safety assessments are performed throughout the investigational period. Subjects return for an ESV at least 7 days after the last 11 day on-site period, or after withdrawal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• BMI between 18.5 and 30.0 kg/m2, inclusive.

Exclusion Criteria:

• Known or suspected hypersensitivity to solifenacin, tamsulosin or any of the other recipients of EC905.

• Any of the contraindications or precautions for use as mentioned in the applicable sections of the Summary of Product Characteristics (SPC) 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.

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

Locations

Country	Name	City	State
United Kingdom	Parexel Early Phase Clinical Unit	Harrow

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	Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma	area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)	Days 1-11, 18-28, 35-45	No
Primary	Pharmacokinetic parameter of solifenacin by maximum concentration (Cmax) in plasma	maximum concentration (Cmax)	Days 1-11, 18-28, 35-45	No
Primary	Pharmacokinetic parameter of tamsulosin HCl by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma	area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)	Days 1-11, 18-28, 35-45	No
Primary	Pharmacokinetic parameter of tamsulosin HCl by maximum concentration (Cmax) in plasma	maximum concentration (Cmax)	Days 1-11, 18-28, 35-45	No
Secondary	Pharmacokinetics profile of solifenacin concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)	(plasma) AUC extrapolated until time = infinity (AUCinf), apparent terminal elimination half-life (t1/2), time to attain Cmax (tmax), apparent total body clearance (CL/F), apparent volume of distribution during the terminal phase (Vz/F)	Days 1-11, 18-28, 35-45	No
Secondary	Pharmacokinetics profile of tamsulosin HCl concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)	(plasma) AUC extrapolated until time = infinity (AUCinf), apparent terminal elimination half-life (t1/2), time to attain Cmax (tmax), apparent total body clearance (CL/F), apparent volume of distribution during the terminal phase (Vz/F)	Days 1-11, 18-28, 35-45	No
Secondary	Safety and tolerability of single doses of EC905 (solifenacin/tamsulosin HCl) under fed or fasted conditions	Adverse events, clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination	Screening (Day-21 to -1) to ESV (at least 7 days after the last 11 day on-site period, or after withdrawal)	No

External Links

•   Link to Results on JAPIC