Healthy VolunteersPhase 1NCT01284868
A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.
A Phase 1 study testing mirabegron, Bisoprolol and propranolol in people with Healthy Volunteers and Pharmacodynamics of Mirabegron, run by Astellas Pharma Inc at 1 site in France.
Trial summary
To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacodynamics of Mirabegron
- What is being tested?
- mirabegron, Bisoprolol and propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Nov 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 20.0 and 28.5 kg/m2, inclusive
- Subject is genotyped as an extensive metabolizer for CYP2D6
- Subject agrees to sexual abstinence and/or use of a highly effective method of birth control from screening until 3 months after last dose of study medication. Examples of effective methods:
- subject's sexual partner has been surgically sterilized (for at least 3 months prior to screening), or
- subject/subject's sexual partner is using standard oral contraception or is practicing two (2) of the following contraceptive methods:
- diaphragm with spermicide
- intrauterine device
- condoms in combination with a spermicidal cream
Who cannot join
- Known or suspected hypersensitivity to mirabegron, propranolol or bisoprolol, or any components of the formulations used
- Any of the liver function tests (i.e. ALT, AST) above the upper limit of normal at repeated measures
- Any clinically significant history of bronchospasm, asthma, eczema, allergic rhinitis during the pollen season, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any clinically significant history of sinus bradycardia, first and second degree atrioventricular block, metabolic acidosis, Raynaud's disease, cardiogenic shock, right ventricular failure secondary to pulmonary hypertension, bronchospasms, angina, peripheral arterial occlusive disease, overt cardiac failure, congestive heart failure, sick sinus syndrome or any other cardiovascular or ECG abnormalities
- 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
Show all 24Show fewer
- Abnormal heart rate and/or blood pressure measurements at the pre-study visit as follows: Heart rate <50 or >90 bpm; mean systolic blood pressure <90 or >140 mmHg; mean diastolic blood pressure <40 or >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 minutes; heart rate will be measured automatically)
- A marked baseline prolongation of QT/QTc interval after repeated measurements of > 430 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
- PR interval > 200 ms or < 120 ms
- Evidence of second- or third-degree atrioventricular block
- Electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block or incomplete LBBB
- Intraventricular conduction delay with QRS duration > 120 ms
- Pathological Q-waves (defined as Q-wave > 40 ms or depth greater than 0.4 - 0.5 mV)
- Evidence of ventricular pre-excitation
- Use of any prescribed or OTC 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 = 200 ml of beer or 25 ml of spirits or 75 ml 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
- Subjects who, in the opinion of the investigator, are 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 Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects.
To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.
Read the detailed description
Impedance cardiography parameters will be assessed and compared when mirabegron (or placebo), is taken in combination with a selective beta-blocker, a non-selective beta-blocker or placebo.
- Conditions
- Healthy Volunteers, Pharmacodynamics of Mirabegron
- Being tested
- mirabegron, Bisoprolol, propranolol, placebo
- Keywords
- Mechanisms of Pharmacological Action, Pharmacodynamics, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called YM178
oral
BisoprololDrug
oral
propranololDrug
oral
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Experimental | Not described Receives: Drug: mirabegron; Drug: Bisoprolol; Drug: propranolol; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma renin activity
Measured: 12 hours
Impedance cardiography
Measured: 12 hours
Secondary outcomes (1)
Pharmacokinetic assessment of mirabegron by analysis of plasma samples
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284868
- Sponsor's protocol ID
- 178-CL-053
- Other IDs
- 2006-004653-14
- Status last verified
- Jan 2011
- First submitted
- 23 Jan 2011
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT01284868
- Acronym / sponsor ID
- 178-CL-053
- Conditions
- Healthy Volunteers, Pharmacodynamics of Mirabegron
- Keywords
- Mechanisms of Pharmacological Action, Pharmacodynamics, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Jan 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.
To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.
Detailed description
Impedance cardiography parameters will be assessed and compared when mirabegron (or placebo), is taken in combination with a selective beta-blocker, a non-selective beta-blocker or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Experimental | Drug: mirabegron, Drug: Bisoprolol, Drug: propranolol, Drug: placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body Mass Index between 20.0 and 28.5 kg/m2, inclusive
- Subject is genotyped as an extensive metabolizer for CYP2D6
- Subject agrees to sexual abstinence and/or use of a highly effective method of birth control from screening until 3 months after last dose of study medication. Examples of effective methods:
Key exclusion criteria (24 listed)
- Known or suspected hypersensitivity to mirabegron, propranolol or bisoprolol, or any components of the formulations used
- Any of the liver function tests (i.e. ALT, AST) above the upper limit of normal at repeated measures
- Any clinically significant history of bronchospasm, asthma, eczema, allergic rhinitis during the pollen season, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any clinically significant history of sinus bradycardia, first and second degree atrioventricular block, metabolic acidosis, Raynaud's disease, cardiogenic shock, right ventricular failure secondary to pulmonary hypertension, bronchospasms, angina, peripheral arterial occlusive disease, overt cardiac failure, congestive heart failure, sick sinus syndrome or any other cardiovascular or ECG abnormalities
- 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
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 | Mirabegron |
| Bisoprololoral | Drug | Mirabegron |
| propranololoral | Drug | Mirabegron |
| placebooral | Drug | Mirabegron |
Primary outcome
Plasma renin activity
Time frame: 12 hours
Impedance cardiography
Time frame: 12 hours
1 secondary outcome
Pharmacokinetic assessment of mirabegron by analysis of plasma samples
Time frame: 12 hours
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 3 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 mirabegron, Bisoprolol and propranolol in people with Healthy Volunteers and Pharmacodynamics 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 8 inclusion and 24 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 3 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?
Plasma renin activity (time frame: 12 hours). 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 3 Jul 2013.