Healthy VolunteerPhase 1NCT01334905
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
A Phase 1 study testing YM178 in people with Healthy Volunteer and Pharmacokinetics of YM178, run by Astellas Pharma Inc at 1 site in Taiwan.
Trial summary
The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetics of YM178
- 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
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Jun 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
- Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
- All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control
Who cannot join
- Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
- Liver function test values above the upper limit of normal
- A history or presence of psychiatric illness, serious active or recurrent infection
- A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
- Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
- Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study
Show all 9Show fewer
- Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study
- A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study
- currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers
The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.
Read the detailed description
A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.
- Conditions
- Healthy Volunteer, Pharmacokinetics of YM178
- Being tested
- YM178
- Keywords
- Overactive Bladder, Urinary incontinence, YM178, mirabegron, Food effect
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
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 |
|---|---|---|
| Part A group | Experimental | fasted condition then fed condition Receives: Drug: YM178 |
| Part B group | Experimental | fed condition then fasted condition Receives: Drug: YM178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of YM178
Measured: Up to 96 hrs post dose
AUC (area under the curve) of YM178 plasma concentration
Measured: Up to 96 hrs post dose
Secondary outcomes (3)
tmax of YM178 plasma concentration
Measured: Up to 96 hrs post dose
t1/2 of YM178 plasma concentration
Measured: Up to 96 hrs post dose
Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.
Measured: Up to 96 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334905
- Sponsor's protocol ID
- 178-CL-092
- Status last verified
- Oct 2011
- First submitted
- 12 Apr 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01334905
- Acronym / sponsor ID
- 178-CL-092
- Conditions
- Healthy Volunteer, Pharmacokinetics of YM178
- Keywords
- Overactive Bladder, Urinary incontinence, YM178, mirabegron, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Apr 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 purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.
Detailed description
A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A group | Experimental | Drug: YM178fasted condition then fed condition |
| Part B group | Experimental | Drug: YM178fed condition then fasted condition |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
- Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
- All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control
Key exclusion criteria (9 listed)
- Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
- Liver function test values above the upper limit of normal
- A history or presence of psychiatric illness, serious active or recurrent infection
- A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
- Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
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 | Part A group, Part B group |
Primary outcome
Maximum plasma concentration (Cmax) of YM178
Time frame: Up to 96 hrs post dose
AUC (area under the curve) of YM178 plasma concentration
Time frame: Up to 96 hrs post dose
3 secondary outcomes
tmax of YM178 plasma concentration
Time frame: Up to 96 hrs post dose
t1/2 of YM178 plasma concentration
Time frame: Up to 96 hrs post dose
Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.
Time frame: Up to 96 hrs post dose
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 12 Jun 2013.
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Screening Protocol
Pain
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 chair
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 Volunteer and Pharmacokinetics of YM178, run by Astellas Pharma Inc at 1 site in Taiwan.
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 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 12 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 Taiwan. 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?
Maximum plasma concentration (Cmax) of YM178 (time frame: Up to 96 hrs post dose). 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 12 Jun 2013.