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Phase 1Phase 1NCT02634489

EC905 Pharmacokinetic Profile Study

A Phase 1 study testing Tamsulosin HCl, Solifenacin Succinate and EC905 in people with Phase 1 and Healthy, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths. 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
Phase 1, Healthy, Benign Prostatic Hyperplasia
What is being tested?
Tamsulosin HCl, Solifenacin Succinate and EC905
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteNetherlands
Study dates
Mar 2009to Jul 2009
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.

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 liver function tests above the upper limit of normal at repeated measurements.
  • Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any other drug (excluding non-active hay fever).
  • Subject is at risk of urinary retention based on medical history.
  • A planned cataract surgery within 30 days after completion of the study.
  • Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests.
Show all 17Show fewer
  • 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 5 min; pulse will be measured automatically).
  • A marked baseline prolongation of QT/QTc interval after repeated measurements of 450 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 occasional use of paracetamol (up to 3 g/day).
  • Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) 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 = 270 cc of beer or 40 cc of spirits or 1 glass of wine) 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. An exception is (partly) participation in Astellas study 905-CL-071, provided a washout of at least 12 days is considered prior to re-enrolment.
  • Employee of the Astellas Group or CRO involved in the study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Site NL1

    Zuidlaren, Drenthe, 9471 GP

Other trials in Netherlands

About this study

Official title: An Open-label, Parallel Group, Randomized, Two-way Crossover, Multiple Dose Study to Compare the Pharmacokinetic Profiles of Solifenacin Succinate and Tamsulosin HCl Following Co-administration of Single Entity Tablets and Administration of Three Different Dose Strengths of the Combination Tablet EC905

A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths.

Read the detailed description

There will be 3 dose cohorts of 15 subjects each. In Period 1, subjects will be randomized to either receive multiple doses of both tamsulosin HCl and solifenacin succinate as single entity tablets, or the combination tablet EC905. The alternate treatment will be provided in Period 2. The cohorts will be balanced for period effects and first-order carry over effects.

Being tested
Tamsulosin HCl, Solifenacin Succinate, EC905
Keywords
Bladder outlet obstruction, Overactive bladder, Urinary incontinence, Omnic OCAS®, Vesicare®, Tamsulosin hydrochloride, Solifenacin succinate
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction, Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tamsulosin HClDrug

    Also called Omnic OCAS®

    Oral

  • Solifenacin SuccinateDrug

    Also called Vesicare®

    Oral

  • EC905Drug

    Also called Vesomni®

    Oral

Study groups in NCT02634489
Study groupRoleWhat they receive
Tamsulosin HCl and Solifenacin SuccinateActive comparatorParticipants will receive daily doses of tamsulosin HCL and Solifenacin Succinate (3 dose strengths) as single tablets.
Receives: Drug: Tamsulosin HCl; Drug: Solifenacin Succinate
EC905 (tamsulosin HCI and solifenacin succinate)Active comparatorParticipants will receive a fixed combination tablet (3 dose strengths).
Receives: Drug: EC905

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK) of tamsulosin HCl and solifenacin succinate in plasma: AUCtau

    AUCtau: area under the concentration - time curve (AUC) during the time interval between consecutive dosing

    Measured: Day 12

  2. PK of tamsulosin HCl and solifenacin succinate in plasma: Cmax

    Cmax: maximum concentration

    Measured: Day 12

Secondary outcomes (4)

  1. Safety profile assessed by adverse events, physical examination and vital signs, routine safety laboratory tests, and 12-lead ECG

    Vital signs include blood pressure, pulse rate. Safety laboratory test includes urinalysis, hematology, and biochemistry. ECG: Electrocardiogram

    Measured: Day 0 up to and including the post study visit (the PSV is scheduled between 7 to 14 days after (early) discharge on study day 13)

  2. PK profile Ctrough

    Ctrough: Trough concentration

    Measured: Day 10, 11, 12, 13

  3. PK profile PTR

    PTR: Peak Trough Ratio

    Measured: Day 12

  4. PK profile Tmax

    Tmax: Time to attain Cmax

    Measured: Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2015 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02634489
Sponsor's protocol ID
905-CL-071
Other IDs
2007-005155-41
Status last verified
Dec 2015
First submitted
16 Dec 2015
Last updated
18 Dec 2015
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tamsulosin HCl, Solifenacin Succinate and EC905 in people with Phase 1 and Healthy, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.

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 18 Dec 2015. 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 Netherlands. 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?

Pharmacokinetics (PK) of tamsulosin HCl and solifenacin succinate in plasma: AUCtau (time frame: Day 12). 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?

On the ClinicalTrials.gov record for NCT02634489.

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 18 Dec 2015.

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