Healthy Chinese VolunteersPhase 1NCT01720212
Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
A Phase 1 study testing YM178 in people with Healthy Chinese Volunteers, run by Astellas Pharma China, Inc. at 1 site in China.
Trial summary
To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Chinese Volunteers
- What is being tested?
- YM178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Aug 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
- Good health status
- The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.
Who cannot join
- The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
- Drug abusers and alcoholics.
- The subject who has consumed alcohol within 36 hours before administration.
- The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
- The subject who is positive for human immunodeficiency virus (HIV).
- The subject who consumes more than 1L tea and coffee per day.
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- Smokers.
- The subject who has donated or lost over 200 mL blood
- The subject who has participated in other clinical trials
- The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
- The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
- Psychopath.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
- Conditions
- Healthy Chinese Volunteers
- Being tested
- YM178
- Keywords
- YM178, Mirabegron, OCAS, Chinese Healthy Volunteers, PK, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM178Drug
Also called Mirabegron
oral
| Study group | Role | What they receive |
|---|---|---|
| Single dose group | Experimental | Not described Receives: Drug: YM178 |
| Multiple dose group | Experimental | Not described Receives: Drug: YM178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of YM178 assessed by the plasma concentration changes
Measured: Up to 96 hours after administration
Cmax of YM178 assessed by the plasma concentration changes
Measured: Up to 96 hours after administration
t1/2 of YM178 assessed by the plasma concentration changes
Measured: Up to 96 hours after administration
Secondary outcomes (1)
Safety assessment of YM178
Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
Measured: Up to 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Chinese 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720212
- Sponsor's protocol ID
- 178-CL-091
- Status last verified
- Oct 2012
- First submitted
- 31 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT01720212
- Acronym / sponsor ID
- 178-CL-091
- Conditions
- Healthy Chinese Volunteers
- Keywords
- YM178, Mirabegron, OCAS, Chinese Healthy Volunteers, PK, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Nov 2012 (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 evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose group | Experimental | Drug: YM178 |
| Multiple dose group | Experimental | Drug: YM178 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
- Good health status
- The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.
Key exclusion criteria (12 listed)
- The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
- Drug abusers and alcoholics.
- The subject who has consumed alcohol within 36 hours before administration.
- The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
- The subject who is positive for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| YM178Also: Mirabegronoral | Drug | Multiple dose group, Single dose group |
Primary outcome
AUC of YM178 assessed by the plasma concentration changes
Time frame: Up to 96 hours after administration
Cmax of YM178 assessed by the plasma concentration changes
Time frame: Up to 96 hours after administration
t1/2 of YM178 assessed by the plasma concentration changes
Time frame: Up to 96 hours after administration
1 secondary outcome
Safety assessment of YM178
Time frame: Up to 33 days
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 2 Nov 2012.
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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.
Medical Director study director
Astellas Pharma Inc
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 YM178 in people with Healthy Chinese Volunteers, run by Astellas Pharma China, Inc. at 1 site in China.
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 3 inclusion and 12 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 2 Nov 2012. 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 China. 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?
AUC of YM178 assessed by the plasma concentration changes (time frame: Up to 96 hours after administration). The study lists 3 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 2 Nov 2012.