Pharmacokinetics of MirabegronPhase 1NCT01478529
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
A Phase 1 study testing mirabegron OCAS and mirabegron in people with Pharmacokinetics of Mirabegron and Bioavailability, run by Astellas Pharma Inc at 1 site in Netherlands.
Trial summary
A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Mirabegron, Bioavailability, Healthy Subjects
- What is being tested?
- mirabegron OCAS and mirabegron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2006to Mar 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2
Who cannot join
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
- Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 ųmol/L; ASAT, ALAT or LDH> 2x ULN; ɣ-GT > 3x ULN and/or abnormal serum bilirubin
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Subjects taking β blockers or β agonists (eye drops allowed)
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to the first admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, ophthalmologic, renal, hepatic, neurological, dermatological, psychiatric or metabolic
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- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- QTcB interval of > 430 (mean QTcB of two measurements > 430msec)
- Abnormal pulse rate measurement (<40 or >90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min.
- Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows:
- Systolic blood pressure <95 or >160 mmHg
- Diastolic blood pressure <40 or >90 mmHg
- Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of > 20 mmHg in systolic blood pressure after 2 min standing and an increase in pulse rate of ≥ 20 bpm
- Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to first admission to the Research Unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation
A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.
Read the detailed description
All participants will receive both oral and iv formulations, separated by a washout period. Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a higher dose of mirabegron.
- Being tested
- mirabegron OCAS, mirabegron
- Keywords
- Pharmacokinetics, Mirabegron, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegron OCASDrug
Also called YM178 OCAS
oral administration
mirabegronDrug
Also called YM178
iv administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | low dose of mirabegron Receives: Drug: mirabegron OCAS; Drug: mirabegron |
| Treatment Arm B | Experimental | high dose of mirabegron Receives: Drug: mirabegron OCAS; Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetics of mirabegron assessed by plasma concentration
Measured: Pre-dose until 72 hours after dosing
Secondary outcomes (1)
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Measured: Baseline until 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startFeb 2006
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetics of MirabegronStudies 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
- 12 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
- NCT01478529
- Sponsor's protocol ID
- 178-CL-033
- Status last verified
- Jun 2013
- First submitted
- 21 Nov 2011
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J, van Marle S, Grunenberg N, Kowalski D, Drogendijk T, Moy S, Iitsuka H, van Gelderen M, Matsushima H, Sawamoto T. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a beta(3)-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.
PubMed 22943933
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation
- ClinicalTrials.gov ID
- NCT01478529
- Acronym / sponsor ID
- 178-CL-033
- Keywords
- Pharmacokinetics, Mirabegron, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 23 Nov 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.
A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.
Detailed description
All participants will receive both oral and iv formulations, separated by a washout period. Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a higher dose of mirabegron.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: mirabegron OCAS, Drug: mirabegronlow dose of mirabegron |
| Treatment Arm B | Experimental | Drug: mirabegron OCAS, Drug: mirabegronhigh dose of mirabegron |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2
Key exclusion criteria (14 listed)
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
- Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 ųmol/L; ASAT, ALAT or LDH> 2x ULN; ɣ-GT > 3x ULN and/or abnormal serum bilirubin
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Subjects taking β blockers or β agonists (eye drops allowed)
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to the first admission to the Research Unit
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 |
|---|---|---|
| mirabegron OCASAlso: YM178 OCASoral administration | Drug | Treatment Arm A, Treatment Arm B |
| mirabegronAlso: YM178iv administration | Drug | Treatment Arm A, Treatment Arm B |
Primary outcome
Assessment of pharmacokinetics of mirabegron assessed by plasma concentration
Time frame: Pre-dose until 72 hours after dosing
1 secondary outcome
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: Baseline until 72 hours after dosing
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 27 Jun 2013.
- Background: PubMed 22943933Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J, van Marle S, Grunenberg N, Kowalski D, Drogendijk T, Moy S, Iitsuka H, van Gelderen M, Matsushima H, Sawamoto T. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a beta(3)-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.
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 OCAS and mirabegron in people with Pharmacokinetics of Mirabegron and Bioavailability, run by Astellas Pharma Inc at 1 site in Netherlands.
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 14 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 27 Jun 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 Netherlands. 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 mirabegron assessed by plasma concentration (time frame: Pre-dose until 72 hours after dosing). 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 NCT01478529, which also lists 1 linked publication.
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 27 Jun 2013.