EC905Phase 1NCT01953861
A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet
A Phase 1 study testing EC905 in people with EC905 and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- EC905, Pharmacokinetics, Healthy Subjects
- What is being tested?
- EC905
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 30.0 kg/m2, inclusive.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- EC905, Pharmacokinetics, Healthy Subjects
- Being tested
- EC905
- Keywords
- Phase I, Combination tablet EC905, Omnic OCAS®, Vesicare®, Food effect, Vesomni, VesiFlow, Urizia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC905Drug
Also called Vesomni, VesiFlow, Urizia
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: fasted | Experimental | EC905 + fasted Receives: Drug: EC905 |
| 2: low-fat breakfast | Experimental | EC905 + low-fat breakfast Receives: Drug: EC905 |
| 3: high-fat breakfast | Experimental | EC905 + high-fat breakfast Receives: Drug: EC905 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Days 1-11, 18-28, 35-45
Pharmacokinetic parameter of solifenacin by maximum concentration (Cmax) in plasma
maximum concentration (Cmax)
Measured: Days 1-11, 18-28, 35-45
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)
Measured: Days 1-11, 18-28, 35-45
Pharmacokinetic parameter of tamsulosin HCl by maximum concentration (Cmax) in plasma
maximum concentration (Cmax)
Measured: Days 1-11, 18-28, 35-45
Secondary outcomes (3)
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)
Measured: Days 1-11, 18-28, 35-45
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)
Measured: Days 1-11, 18-28, 35-45
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
Measured: Screening (Day-21 to -1) to ESV (at least 7 days after the last 11 day on-site period, or after withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EC905Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clincial Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953861
- Sponsor's protocol ID
- 905-CL-054
- Other IDs
- 2009-013419-36, 2009
- Status last verified
- May 2014
- First submitted
- 26 Sep 2013
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01953861
- Acronym / sponsor ID
- 905-CL-054
- Conditions
- EC905, Pharmacokinetics, Healthy Subjects
- Keywords
- Phase I, Combination tablet EC905, Omnic OCAS®, Vesicare®, Food effect, Vesomni, VesiFlow, Urizia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: fasted | Experimental | Drug: EC905EC905 + fasted |
| 2: low-fat breakfast | Experimental | Drug: EC905EC905 + low-fat breakfast |
| 3: high-fat breakfast | Experimental | Drug: EC905EC905 + high-fat breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 18.5 and 30.0 kg/m2, inclusive.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC905Also: Vesomni, VesiFlow, UriziaOral | Drug | 1: fasted, 2: low-fat breakfast, 3: high-fat breakfast |
Primary outcome
Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma
Time frame: Days 1-11, 18-28, 35-45
area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)
Pharmacokinetic parameter of solifenacin by maximum concentration (Cmax) in plasma
Time frame: Days 1-11, 18-28, 35-45
maximum concentration (Cmax)
Pharmacokinetic parameter of tamsulosin HCl by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma
Time frame: Days 1-11, 18-28, 35-45
area under the plasma concentration - time curve (AUC) from the time of dosing until the last measurable concentration (AUClast)
Pharmacokinetic parameter of tamsulosin HCl by maximum concentration (Cmax) in plasma
Time frame: Days 1-11, 18-28, 35-45
maximum concentration (Cmax)
3 secondary outcomes
Pharmacokinetics profile of solifenacin concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)
Time frame: Days 1-11, 18-28, 35-45
Pharmacokinetics profile of tamsulosin HCl concentration: (AUCinf), (t1/2), (tmax), (CL/F) and (Vz/F)
Time frame: Days 1-11, 18-28, 35-45
Safety and tolerability of single doses of EC905 (solifenacin/tamsulosin HCl) under fed or fasted conditions
Time frame: Screening (Day-21 to -1) to ESV (at least 7 days after the last 11 day on-site period, or after withdrawal)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clincial Study Manager study chair
Astellas Pharma Europe B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EC905 in people with EC905 and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter of solifenacin by Area Under the Curve from the time of dosing until the last measurable concentration (AUClast) in plasma (time frame: Days 1-11, 18-28, 35-45). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.