Healthy VolunteersPhase 1NCT01297192
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
A Phase 1 study testing solifenacin succinate and mirabegron in people with Healthy Volunteers and Pharmacokinetics of Mirabegron, run by Astellas Pharma Inc at 1 site in France.
Trial summary
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacokinetics of Mirabegron
- What is being tested?
- solifenacin succinate and mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject must agree to sexual abstinence and/or use a highly effective method of birth control from screening until 3 months after last dose of study medication
- Female subject must be of non-child bearing potential, i.e. post menopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice an adequate non-hormonal contraceptive method to prevent pregnancies. Non-hormonal contraceptive methods are defined as:
- sexual abstinence from 1 month before admission until 3 months after discharge
- subject's sexual partner has been surgically sterilized (since at least 3 months prior to the screening), or
- subject is under two (2) of the following contraceptive methods: I. diaphragm with spermicide II. intrauterine device III. sexual partner is using condoms in combination with a spermicidal cream
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Who cannot join
- Known or suspected hypersensitivity to mirabegron or any of the components of the formulation used
- Known or suspected hypersensitivity to solifenacin succinate or any of the components of the formulation used
- Pregnant or breast feeding within 6 months before screening assessment.
- Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal at repeated measures
- Any clinical significant history of or at risk for urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma
- 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)
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- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 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 measurement 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, oral contraceptives or hormone replacement therapy, 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, 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) (>14 units of alcohol for female subjects) 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
- Subject who, in the opinion of the investigator, is not likely to complete the trial for any reason
- 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
- Any clinical condition, which, in the opinion of the investigator, would not allow safe completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirabegron in Healthy Young Male and Female Subjects
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
- Conditions
- Healthy Volunteers, Pharmacokinetics of Mirabegron
- Being tested
- solifenacin succinate, mirabegron
- Keywords
- YM178, Mirabegron, DDI, Phase I, Solifenacin, Pharmacokinetics, Pharmacokinetics of mirabegron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinateDrug
Also called Vesicare, YM905
Oral
mirabegronDrug
Also called YM178
Oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Other | The effect of mirabegron on the pharmacokinetics of solifenacin Receives: Drug: solifenacin succinate; Drug: mirabegron |
| Treatment Arm 2 | Other | The effect of solifenacin on the pharmacokinetics of mirabegron Receives: Drug: solifenacin succinate; Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetics of solifenacin through analysis of blood samples
Measured: Days 1 - 9 and Days 23 - 39
Assessment of pharmacokinetics of mirabegron through analysis of blood samples
Measured: Time Frame: Days 1 - 6 and Days 16 - 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297192
- Sponsor's protocol ID
- 178-CL-069
- Other IDs
- 2008-007929-40, 2008
- Status last verified
- Jul 2013
- First submitted
- 15 Feb 2011
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirabegron in Healthy Young Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01297192
- Acronym / sponsor ID
- 178-CL-069
- Conditions
- Healthy Volunteers, Pharmacokinetics of Mirabegron
- Keywords
- YM178, Mirabegron, DDI, Phase I, Solifenacin, Pharmacokinetics, Pharmacokinetics of mirabegron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Feb 2011 (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.
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Other | Drug: solifenacin succinate, Drug: mirabegronThe effect of mirabegron on the pharmacokinetics of solifenacin |
| Treatment Arm 2 | Other | Drug: solifenacin succinate, Drug: mirabegronThe effect of solifenacin on the pharmacokinetics of mirabegron |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subject must agree to sexual abstinence and/or use a highly effective method of birth control from screening until 3 months after last dose of study medication
- Female subject must be of non-child bearing potential, i.e. post menopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice an adequate non-hormonal contraceptive method to prevent pregnancies. Non-hormonal contraceptive methods are defined as:
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Key exclusion criteria (20 listed)
- Known or suspected hypersensitivity to mirabegron or any of the components of the formulation used
- Known or suspected hypersensitivity to solifenacin succinate or any of the components of the formulation used
- Pregnant or breast feeding within 6 months before screening assessment.
- Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal at repeated measures
- Any clinical significant history of or at risk for urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma
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 |
|---|---|---|
| solifenacin succinateAlso: Vesicare, YM905Oral | Drug | Treatment Arm 1, Treatment Arm 2 |
| mirabegronAlso: YM178Oral | Drug | Treatment Arm 1, Treatment Arm 2 |
Primary outcome
Assessment of pharmacokinetics of solifenacin through analysis of blood samples
Time frame: Days 1 - 9 and Days 23 - 39
Assessment of pharmacokinetics of mirabegron through analysis of blood samples
Time frame: Time Frame: Days 1 - 6 and Days 16 - 21
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 Jul 2013.
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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.
Use Central Contact 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 solifenacin succinate and mirabegron in people with Healthy Volunteers and Pharmacokinetics of Mirabegron, run by Astellas Pharma Inc at 1 site in France.
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 6 inclusion and 20 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 Jul 2013. 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 France. 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?
Assessment of pharmacokinetics of solifenacin through analysis of blood samples (time frame: Days 1 - 9 and Days 23 - 39). 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 Jul 2013.