Phase 1Phase 1NCT02010944
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
A Phase 1 study testing solifenacin succinate, mirabegron and mirabegron/solifenacin succinate in people with Phase 1 and Bioavailability, run by Astellas Pharma Europe B.V. at 1 site in Germany.
Trial summary
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1, Bioavailability, Healthy Subjects
- What is being tested?
- solifenacin succinate, mirabegron and mirabegron/solifenacin succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Nov 2012
- 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 not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.
- Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.
Who cannot join
- Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.
- Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.
- Any significant blood loss, donated one unit (450 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 clinic admission on Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Three Dose Strengths in Healthy Male and Female Subjects
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.
Read the detailed description
There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.
The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.
Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.
Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.
An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.
- Conditions
- Phase 1, Bioavailability, Healthy Subjects
- Being tested
- solifenacin succinate, mirabegron, mirabegron/solifenacin succinate
- Keywords
- Solifenacin, Mirabegron, Fixed-dose combination (FDC), Single Entity Tablet (SET), Pharmacokinetics, Bioavailability
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
mirabegron/solifenacin succinateDrug
Also called YM178/YM905
oral
| Study group | Role | What they receive |
|---|---|---|
| 1: FDC-SET-SET | Experimental | Fixed Dose Combination followed by two periods of the Single Entity Tablets Receives: Drug: solifenacin succinate; Drug: mirabegron; Drug: mirabegron/solifenacin succinate |
| 2: SET-FDC-FDC | Experimental | Single Entity Tablets followed by two periods of Fixed Dose Combination Receives: Drug: solifenacin succinate; Drug: mirabegron; Drug: mirabegron/solifenacin succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of solifenacin in plasma as measured by Cmax (Maximum concentration)
Measured: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by AUClast (AUC until last sample taken)
Measured: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity)
Measured: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by Cmax (Maximum concentration)
Measured: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUClast (AUC until last sample taken)
Measured: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUCinf (AUC extrapolated until infinity)
Measured: Days 1-11
Secondary outcomes (3)
Pharmacokinetic profile of Solifenacin in plasma
AUC0-72h (Area under the plasma concentration-time curve from time zero to 72h), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance)
Measured: Days 1-11
Pharmacokinetic profile of mirabegron in plasma
AUC0-72h (Area under the plasma concentration-time curve from time zero to 72h), tmax (Time to attain Cmax), tlag (Absorption lag time), t1/2 (Apparent terminal elimination half-life), Vz/F (Apparent volume of distribution), CL/F (Apparent total body plasma clearance)
Measured: Days 1-11
Safety and tolerability of solifenacin succinate and mirabegron assessed by adverse events, vital signs, laboratory tests, physical examination and 12-lead electrocardiogram (ECG)
Measured: Screening to End of Study Visit (Day 11 Period 3 or within 7 to 14 days after discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- 72 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
- NCT02010944
- Sponsor's protocol ID
- 178-CL-103
- Other IDs
- 2012-002650-23
- Status last verified
- Oct 2013
- First submitted
- 4 Oct 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Three Dose Strengths in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02010944
- Acronym / sponsor ID
- 178-CL-103
- Conditions
- Phase 1, Bioavailability, Healthy Subjects
- Keywords
- Solifenacin, Mirabegron, Fixed-dose combination (FDC), Single Entity Tablet (SET), Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Dec 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.
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.
Detailed description
There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.
The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.
Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.
Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.
An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: FDC-SET-SET | Experimental | Drug: solifenacin succinate, Drug: mirabegron, Drug: mirabegron/solifenacin succinateFixed Dose Combination followed by two periods of the Single Entity Tablets |
| 2: SET-FDC-FDC | Experimental | Drug: solifenacin succinate, Drug: mirabegron, Drug: mirabegron/solifenacin succinateSingle Entity Tablets followed by two periods of Fixed Dose Combination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male subject must agree to not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.
- Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.
Key exclusion criteria (4 listed)
- Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.
- Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.
- Any significant blood loss, donated one unit (450 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 clinic admission on Day -1.
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 | 1: FDC-SET-SET, 2: SET-FDC-FDC |
| mirabegronAlso: YM178oral | Drug | 1: FDC-SET-SET, 2: SET-FDC-FDC |
| mirabegron/solifenacin succinateAlso: YM178/YM905oral | Drug | 1: FDC-SET-SET, 2: SET-FDC-FDC |
Primary outcome
Pharmacokinetic parameter of solifenacin in plasma as measured by Cmax (Maximum concentration)
Time frame: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by AUClast (AUC until last sample taken)
Time frame: Days 1-11
Pharmacokinetic parameter of solifenacin in plasma as measured by AUCinf (AUC extrapolated until infinity)
Time frame: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by Cmax (Maximum concentration)
Time frame: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUClast (AUC until last sample taken)
Time frame: Days 1-11
Pharmacokinetic parameter of mirabegron in plasma as measured by AUCinf (AUC extrapolated until infinity)
Time frame: Days 1-11
3 secondary outcomes
Pharmacokinetic profile of Solifenacin in plasma
Time frame: Days 1-11
Pharmacokinetic profile of mirabegron in plasma
Time frame: Days 1-11
Safety and tolerability of solifenacin succinate and mirabegron assessed by adverse events, vital signs, laboratory tests, physical examination and 12-lead electrocardiogram (ECG)
Time frame: Screening to End of Study Visit (Day 11 Period 3 or within 7 to 14 days after discontinuation)
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 13 Dec 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.
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 solifenacin succinate, mirabegron and mirabegron/solifenacin succinate in people with Phase 1 and Bioavailability, 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 2 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 13 Dec 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 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 of solifenacin in plasma as measured by Cmax (Maximum concentration) (time frame: Days 1-11). The study lists 6 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 13 Dec 2013.