EC905Phase 1NCT01953848
A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)
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
Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- EC905, Pharmacokinetics, Multiple Dose
- 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
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 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 45 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older 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 tamsulosin HCl, solifenacin succinate, EC905 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 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 clinic.
- Any of the liver function tests (i.e. ALT, AST) above the upper limit of normal.
- Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
- Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.
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- Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate <40 or >90 bpm; mean systolic blood pressure >160 mmHg; mean diastolic blood pressure >100 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for at least 5 min; pulse rate will be measured automatically).
- A QT interval after repeated measurements of >430 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day).
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit.
- Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit.
- History of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine (12%)) within 3 months prior to admission to the Clinical Unit.
- Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
- Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
- Employee of the Astellas Group or CRO involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Volunteers Over 45 Years of Age
Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.
Read the detailed description
In this study there are two sequence groups with 27 subjects in total. In Period 1, subjects are randomized to receive one of the two final combination tablet formulations of tamsulosin HCl and solifenacin succinate. In Period 1, 13 subjects receive one combination and 14 subjects receive the other combination. In Period 2, the alternate treatment is provided.
Screening takes place from Days -21 to -2 before the first admission day (Day -1). EC905 is administered from Day 1 to Day 12 (treatment period 1), and from Day 13 to Day 24 (treatment period 2). All treatments are administered with subjects in the fasted state.
Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base are collected, and assessments of vital signs, safety electrocardiogram (ECG), safety laboratory, adverse events and concomitant medications are performed.
Subjects are discharged on day 25 and an End of Study Visit takes place at least 10 days after the second treatment period, or after withdrawal.
- Conditions
- EC905, Pharmacokinetics, Multiple Dose, Healthy Subjects
- Being tested
- EC905
- Keywords
- Phase I, Combination tablet EC905, Steady-state, 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 tamsulosin HCl and solifenacin succinate
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: Low dose EC905 | Experimental | Not described Receives: Drug: EC905 |
| 2: High dose EC905 | Experimental | Not described Receives: Drug: EC905 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of tamsulosin HCl by Area Under the Curve during the time interval between consecutive dosing
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of tamsulosin HCl by Maximum concentration
Maximum concentration ( Cmax)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of solifenacin succinate by Area Under the Curve during the time interval between consecutive dosing
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetic profile of solifenacin succinate by Cmax (Maximum concentration)
Maximum concentration ( Cmax)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Secondary outcomes (3)
Pharmacokinetics profile of tamsulosin HCl concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Observed trough concentration (Ctrough), Peak Trough Ratio (PTR), time to attain Cmax (tmax), apparent total body clearance (CL/F)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetics profile of solifenacin succinate concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Observed trough concentration (Ctrough), Peak Trough Ratio (PTR), time to attain Cmax (tmax), apparent total body clearance (CL/F)
Measured: Days 10-12 and Days 13, 22-25 (26 times)
Safety and tolerability of EC905
Adverse events, ECG, vital signs, safety laboratory assessments, physical examination
Measured: Day -21 to End of Study Visit
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 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953848
- Sponsor's protocol ID
- 905-CL-053
- Other IDs
- 2009-015078-36, 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, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Volunteers Over 45 Years of Age
- ClinicalTrials.gov ID
- NCT01953848
- Acronym / sponsor ID
- 905-CL-053
- Conditions
- EC905, Pharmacokinetics, Multiple Dose, Healthy Subjects
- Keywords
- Phase I, Combination tablet EC905, Steady-state, Vesomni, VesiFlow, Urizia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Apr 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.
Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.
Detailed description
In this study there are two sequence groups with 27 subjects in total. In Period 1, subjects are randomized to receive one of the two final combination tablet formulations of tamsulosin HCl and solifenacin succinate. In Period 1, 13 subjects receive one combination and 14 subjects receive the other combination. In Period 2, the alternate treatment is provided.
Screening takes place from Days -21 to -2 before the first admission day (Day -1). EC905 is administered from Day 1 to Day 12 (treatment period 1), and from Day 13 to Day 24 (treatment period 2). All treatments are administered with subjects in the fasted state.
Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base are collected, and assessments of vital signs, safety electrocardiogram (ECG), safety laboratory, adverse events and concomitant medications are performed.
Subjects are discharged on day 25 and an End of Study Visit takes place at least 10 days after the second treatment period, or after withdrawal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Low dose EC905 | Experimental | Drug: EC905 |
| 2: High dose EC905 | Experimental | Drug: EC905 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive.
Key exclusion criteria (17 listed)
- Known or suspected hypersensitivity to tamsulosin HCl, solifenacin succinate, EC905 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 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 clinic.
- Any of the liver function tests (i.e. ALT, AST) above the upper limit of normal.
- Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
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: tamsulosin HCl and solifenacin succinateOral | Drug | 1: Low dose EC905, 2: High dose EC905 |
Primary outcome
Pharmacokinetic profile of tamsulosin HCl by Area Under the Curve during the time interval between consecutive dosing
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Pharmacokinetic profile of tamsulosin HCl by Maximum concentration
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Maximum concentration ( Cmax)
Pharmacokinetic profile of solifenacin succinate by Area Under the Curve during the time interval between consecutive dosing
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)
Pharmacokinetic profile of solifenacin succinate by Cmax (Maximum concentration)
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Maximum concentration ( Cmax)
3 secondary outcomes
Pharmacokinetics profile of tamsulosin HCl concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Pharmacokinetics profile of solifenacin succinate concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance
Time frame: Days 10-12 and Days 13, 22-25 (26 times)
Safety and tolerability of EC905
Time frame: Day -21 to End of Study Visit
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.
Medical Monitor study director
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 17 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 profile of tamsulosin HCl by Area Under the Curve during the time interval between consecutive dosing (time frame: Days 10-12 and Days 13, 22-25 (26 times)). 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.