CardiovascularPhase 1NCT01489696
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
A Phase 1 study testing mirabegron and tamsulosin in people with Cardiovascular and Healthy Subjects, run by Astellas Pharma Inc at 1 site in United Kingdom.
Trial summary
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular, Healthy Subjects, Pharmacokinetics
- What is being tested?
- mirabegron and tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Feb 2011
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2
Who cannot join
- Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
- Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any prior clinically significant psychiatric history including hospitalization for mental health management
- Subject is at risk of urinary retention based on medical history
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests
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- Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate <50 or >90 bpm; mean systolic blood pressure <90 mm Hg or >140 mmHg (>160 mmHg for subjects 65 years or older); mean diastolic blood pressure <60 mm Hg or >90 mmHg (>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)
- A QTc interval of > 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
- A hemoglobin value <12.5 g/dl (7.8 mmol/l) and/or a hematocrit value <37.9% and/or a Red Blood Cell count <4.08 T/l (4080 mm3)
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
Read the detailed description
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.
24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.
- Conditions
- Cardiovascular, Healthy Subjects, Pharmacokinetics
- Being tested
- mirabegron, tamsulosin
- Keywords
- Pharmacokinetics, Mirabegron, Tamsulosin, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called YM178
oral
tamsulosinDrug
Also called Flomax, Harnal, Omnic
oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | tamsulosin singles doses; mirabegron multiple dose Receives: Drug: mirabegron; Drug: tamsulosin |
| Treatment Arm 2 | Experimental | mirabegron single doses; tamsulosin multiple dose Receives: Drug: mirabegron; Drug: tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular interactions assessed by blood pressure and pulse rate
Measured: Pre-dose until 24 hours after dosing
Secondary outcomes (2)
Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events
Measured: Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose
Potential PK interaction of the combination dosing assessed by serial plasma sampling
Measured: Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489696
- Sponsor's protocol ID
- 178-CL-080
- Other IDs
- 2010-018690-38
- Status last verified
- Dec 2011
- First submitted
- 21 Nov 2011
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
- ClinicalTrials.gov ID
- NCT01489696
- Acronym / sponsor ID
- 178-CL-080
- Conditions
- Cardiovascular, Healthy Subjects, Pharmacokinetics
- Keywords
- Pharmacokinetics, Mirabegron, Tamsulosin, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Dec 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.
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
Detailed description
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.
24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: mirabegron, Drug: tamsulosintamsulosin singles doses; mirabegron multiple dose |
| Treatment Arm 2 | Experimental | Drug: mirabegron, Drug: tamsulosinmirabegron single doses; tamsulosin multiple dose |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
- Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any prior clinically significant psychiatric history including hospitalization for mental health management
- Subject is at risk of urinary retention based on medical history
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 |
|---|---|---|
| mirabegronAlso: YM178oral | Drug | Treatment Arm 1, Treatment Arm 2 |
| tamsulosinAlso: Flomax, Harnal, Omnicoral | Drug | Treatment Arm 1, Treatment Arm 2 |
Primary outcome
Cardiovascular interactions assessed by blood pressure and pulse rate
Time frame: Pre-dose until 24 hours after dosing
2 secondary outcomes
Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events
Time frame: Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose
Potential PK interaction of the combination dosing assessed by serial plasma sampling
Time frame: Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points)
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 9 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.
Clinical 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 mirabegron and tamsulosin in people with Cardiovascular and Healthy Subjects, run by Astellas Pharma Inc 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 9 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 9 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 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?
Cardiovascular interactions assessed by blood pressure and pulse rate (time frame: Pre-dose until 24 hours after dosing). 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 9 Dec 2013.