EC905Phase 1NCT01953887
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
A Phase 1 study testing EC905, solifenacin and tamsulosin in people with EC905 and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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®). 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, solifenacin and tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Jul 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
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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®)
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.
Read the 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.
- Conditions
- EC905, Pharmacokinetics, Healthy Subjects
- Being tested
- EC905, solifenacin, tamsulosin
- Keywords
- Phase I, Final formulation EC905, Solifenacin succinate, Tamsulosin HCl, Marketed drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC905Drug
Oral
solifenacinDrug
Also called Vesicare®
oral
tamsulosinDrug
Also called Omnic OCAS®
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 combination tablet EC905 | Experimental | Not described Receives: Drug: EC905 |
| 2: solifenacin | Experimental | Not described Receives: Drug: solifenacin |
| 3: tamsulosin | Experimental | Not described Receives: Drug: tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Predose to Day 10 after dosing (22 times)
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)
Measured: Predose to Day 10 after dosing (22 times)
Secondary outcomes (2)
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)
Measured: Predose to Day 10 after dosing (22 times)
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
Measured: Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), 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 startMar 2010
- Primary completionJul 2010
- Study completionJul 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953887
- Sponsor's protocol ID
- 905-CL-072
- Other IDs
- 2009-015618-22, 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, 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®)
- ClinicalTrials.gov ID
- NCT01953887
- Acronym / sponsor ID
- 905-CL-072
- Conditions
- EC905, Pharmacokinetics, Healthy Subjects
- Keywords
- Phase I, Final formulation EC905, Solifenacin succinate, Tamsulosin HCl, Marketed drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 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.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 combination tablet EC905 | Experimental | Drug: EC905 |
| 2: solifenacin | Experimental | Drug: solifenacin |
| 3: tamsulosin | Experimental | Drug: tamsulosin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EC905Oral | Drug | 1 combination tablet EC905 |
| solifenacinAlso: Vesicare®oral | Drug | 2: solifenacin |
| tamsulosinAlso: Omnic OCAS®oral | Drug | 3: tamsulosin |
Primary outcome
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®
Time frame: 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®
Time frame: Predose to Day 10 after dosing (22 times)
AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)
2 secondary outcomes
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®
Time frame: Predose to Day 10 after dosing (22 times)
Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS®
Time frame: Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), 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.
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, solifenacin and tamsulosin 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 4 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?
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® (time frame: Predose to Day 10 after dosing (22 times)). The study lists 2 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.