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Healthy SubjectsPhase 1NCT02169713

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

A Phase 1 study testing Mirabegron, Solifenacin succinate and Tamsulosin HCl in people with Healthy Subjects and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in Germany.

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

The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the safety and tolerability of the combined administration of solifenacin, mirabegron and tamsulosin HCl. Read more about this study

Who is it for?
Ages 45 to 80 years, men onlyHealthy volunteers can take part
What is being tested?
Mirabegron, Solifenacin succinate and Tamsulosin HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteGermany
Study dates
May 2014to Aug 2014
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

  • Subject has a body mass index range of 18.5 to 30.0 kg/m2, inclusive. The subject weighs at least 50 kg [screening].
  • Subject and their female spouse/partners who are of childbearing potential must be using a highly effective form of contraception consisting of 2 forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
  • Subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study while participation in the present clinical study, defined as signing the informed consent form until completion of the last clinical study visit.

Who cannot join

  • Subject has a known or suspected hypersensitivity to solifenacin succinate, mirabegron, tamsulosin HCl or any components of the formulations used including sulfa allergies.
  • Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transferase and/or total bilirubin [TBL]) above 1.5 of the upper limit of normal (ULN). In such a case the assessment may be repeated once [day-1].
  • Subject has any clinically significant history of allergic conditions.
  • Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the Medical Investigator.
  • Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day -2 (admission day).
  • Subject has any clinically significant abnormality following the Investigator's review of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or day -1.
Show all 21Show fewer
  • Subject has a mean pulse rate of < 50 or > 90 bpm; mean systolic BP < 90 mmHg or > 140 mmHg; mean diastolic BP < 60 mmHg or > 90 mmHg at day -1 (vital sign measurements taken in triplicate after subject has been resting in supine position for 10 min; pulse rate will be measured automatically).
  • Subject has a mean QTc(F) interval of > 430 ms (> 450 for subjects aged 65 and above) at day -1. If the mean QTc(F) exceeds the limits above, 1 additional triplicate ECG can be taken.
  • Subject has any clinical significant history of or risk of urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma, orthostatic hypotension.
  • Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease, or a family history of Long QT Syndrome.
  • Subject uses any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies [e.g., St. John's Wort]) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day).
  • Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit on day -2.
  • Subject has a 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 on day -2.
  • Subject has consumed grapefruit (more than 3 x 200 mL) or marmalade (more than 3 times), star fruit, Seville oranges or Seville orange juice-containing products in the week prior to admission to the clinical unit until end of study visit (ESV), as reported by the subject.
  • Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
  • Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit regularly.
  • Subject has significant blood loss, donated 1 unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinical unit admission on day -2.
  • Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis A virus antibodies (Immunoglobulin M), hepatitis C virus antibodies or human immunodeficiency virus 1 + 2 antibodies.
  • Subject participated in any clinical study or has been treated with any investigational drugs within 28 days prior to screening.
  • Subject is a vulnerable subject (e.g., subject kept in detention).
  • Subject is an employee of the Astellas Group or Contract Research Organization involved in the clinical study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Parexel International GmbH

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects

The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the safety and tolerability of the combined administration of solifenacin, mirabegron and tamsulosin HCl.

Read the detailed description

This study is comprised of two study sequences with 2 investigational periods in each sequence. There will be a wash-out period between each investigational period. Patients will be admitted to the clinic until discharged after each investigational period.

Being tested
Mirabegron, Solifenacin succinate, Tamsulosin HCl, Placebo
Keywords
Healthy subjects, Mirabegron, Solifenacin, Tamsulosin HCl

What participants receive

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

  • MirabegronDrug

    Also called Myrbetriq, Betmiga, Betanis

    Oral

  • Solifenacin succinateDrug

    Also called solifenacin, Vesikur, Vesicare

    Oral

  • Tamsulosin HClDrug

    Also called Flomax

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT02169713
Study groupRoleWhat they receive
Treatment Sequence 1ExperimentalTamsulosin HCl alone (with matching placebo for solifenacin and mirabegron) then followed by tamsulosin HCl with solifenacin and mirabegron
Receives: Drug: Mirabegron; Drug: Solifenacin succinate; Drug: Tamsulosin HCl; Drug: Placebo
Treatment Sequence 2ExperimentalTamsulosin HCl with solifenacin and mirabegron then followed by tamsulosin HCl alone (with matching placebo for solifenacin and mirabegron)
Receives: Drug: Mirabegron; Drug: Solifenacin succinate; Drug: Tamsulosin HCl; Drug: Placebo

What is being measured

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

  1. Pharmacokinetic parameter for tamsulosin HCl (plasma) in the absence and presence of solifenacin and mirabegron: Cmax

    Maximum concentration (Cmax)

    Measured: Day 14 in each investigational period

  2. Pharmacokinetic parameter for tamsulosin HCl (plasma) in the absence and presence of solifenacin and mirabegron: AUCtau

    Area under the curve over a dosing interval (AUCtau)

    Measured: Day 14 in each investigational period

Secondary outcomes (4)

  1. Pharmacokinetic parameter for tamsulosin HCl (plasma): Ctrough

    Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Measured: Days 11, 12 and 13 in each investigational period

  2. Pharmacokinetic parameter for tamsulosin HCl (plasma): tmax, CL/F, PTR

    Time after dosing when Cmax occurs (tmax), apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F), Peak-through ratio (PTR)

    Measured: Day 14 in each investigational period

  3. Pharmacokinetic parameter for solifenacin and mirabegron (plasma): Ctrough

    Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Measured: Days 11, 12 and 13 in each investigational period

  4. Pharmacokinetic parameter for solifenacin and mirabegron (plasma): Cmax, AUCtau, tmax, CL/F

    Maximum concentration (Cmax), Area under the curve over a dosing interval (AUCtau), Time after dosing when Cmax occurs (tmax), apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

    Measured: Day 14 in each investigational period

Timeline

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

  1. First posted23 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02169713
Sponsor's protocol ID
178-CL-109
Other IDs
2013-004230-15
Status last verified
Aug 2014
First submitted
5 Jun 2014
Last updated
29 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirabegron, Solifenacin succinate and Tamsulosin HCl in people with Healthy Subjects and Pharmacokinetics, run by Astellas Pharma Europe B.V. at 1 site in Germany.

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 4 inclusion and 21 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 Aug 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 Germany. 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 for tamsulosin HCl (plasma) in the absence and presence of solifenacin and mirabegron: Cmax (time frame: Day 14 in each investigational period). 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 NCT02169713.

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 Aug 2014.

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