Pharmacokinetics of YM178Phase 1NCT01646294
A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions
A Phase 1 study testing YM178 modified release (OCAS) and YM178 immediate release (IR) in people with Pharmacokinetics of YM178 and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.
Trial summary
The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178… 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 YM178, Healthy Subjects
- What is being tested?
- YM178 modified release (OCAS) and YM178 immediate release (IR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to May 2005
- 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 BMI 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 and/or abnormal serum bilirubin
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of upper gastrointestinal symptoms 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, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- QTcB interval of >430 msec at screening (mean QTcB of two measurements>430msec)
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- 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 minutes
- 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 (as outlined in section 12.5) and an increase in pulse rate of ≥ 20 bpm
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to first admission to the Research Unit.
- History of drinking more than 21 units of alcohol per week within 3 months prior to first admission to the Research Unit
- Donation of blood or blood products (more than 400 ml) within 3 months prior to first admission to the Research Unit or plasmapheresis within 4 weeks preceding the start of this study
- Positive serology test for HBsAg, HAV IgM, anti-HCV or anti-HIV 1+2
- Subject who is not willing to complete standard FDA high fat breakfast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Open Label, Three-way Crossover Study to Compare the Pharmacokinetic Profiles of Three Different YM178 Modified Release (OCAS) Formulations Under Fasted and Fed Conditions With YM178 Immediate Release (IR) Formulation Under Fasted Conditions in Healthy Subjects
The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.
Read the detailed description
Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast).
The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.
- Conditions
- Pharmacokinetics of YM178, Healthy Subjects
- Being tested
- YM178 modified release (OCAS), YM178 immediate release (IR)
- Keywords
- Pharmacokinetics, Phase I, YM178, Modified release (Oral Controlled Absorption System (OCAS)), Immediate release (IR), Fasted conditions, Fed conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM178 modified release (OCAS)Drug
Also called mirabegron, Myrebtriq
oral
YM178 immediate release (IR)Drug
Also called mirabegron, Myrebtriq
oral
| Study group | Role | What they receive |
|---|---|---|
| OCAS-F | Experimental | YM178 OCAS tablet (OCAS-Fast) taken orally under fasted and fed condition Receives: Drug: YM178 modified release (OCAS); Drug: YM178 immediate release (IR) |
| OCAS-S | Experimental | YM178 OCAS tablet (OCAS-Slow) taken orally under fasted and fed condition Receives: Drug: YM178 modified release (OCAS); Drug: YM178 immediate release (IR) |
| OCAS-M | Experimental | YM178 OCAS tablet (OCAS-Medium) taken orally under fasted and fed condition Receives: Drug: YM178 modified release (OCAS); Drug: YM178 immediate release (IR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics profile of OCAS and IR assessed by plasma concentration
AUC0-12h (Area under the plasma concentration - time curve from t=0 to t=12h) Cmax (Maximum concentration), tmax (Time to attain Cmax) and Ctrough (Pre-dose plasma concentration)
Measured: Day 1 & Day 6 - Day 8
Pharmacokinetics profile of OCAS assessed by plasma concentration
AUC0-24h (Area under the plasma concentration - time curve from t=0 to t=24h) Cmax, Tmax and Ctrough
Measured: Day 8
Pharmacokinetics profile of IR assessed by plasma concentration
AUC0-12h , AUC12-24h (Area under the plasma concentration - time curve from t=12 to t=24h), AUC0-24h, PTR (Peak trough ratio), Cmax, Tmax and Ctrough
Measured: Day 8
Secondary outcomes (1)
Monitoring of safety parameters through assessment of vital signs, adverse events, Electrocardiogram (ECG) and clinical laboratory assessments
Measured: Baseline until Post Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJan 2005
- Primary completionMay 2005
- Study completionMay 2005
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 YM178Studies 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- 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
- NCT01646294
- Sponsor's protocol ID
- 178-CL-030
- Other IDs
- 2004-003876-12, 2004
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2012
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014.
PubMed 23497763
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Open Label, Three-way Crossover Study to Compare the Pharmacokinetic Profiles of Three Different YM178 Modified Release (OCAS) Formulations Under Fasted and Fed Conditions With YM178 Immediate Release (IR) Formulation Under Fasted Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01646294
- Acronym / sponsor ID
- 178-CL-030
- Conditions
- Pharmacokinetics of YM178, Healthy Subjects
- Keywords
- Pharmacokinetics, Phase I, YM178, Modified release (Oral Controlled Absorption System (OCAS)), Immediate release (IR), Fasted conditions, Fed conditions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Jul 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.
The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.
Detailed description
Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast).
The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCAS-F | Experimental | Drug: YM178 modified release (OCAS), Drug: YM178 immediate release (IR)YM178 OCAS tablet (OCAS-Fast) taken orally under fasted and fed condition |
| OCAS-S | Experimental | Drug: YM178 modified release (OCAS), Drug: YM178 immediate release (IR)YM178 OCAS tablet (OCAS-Slow) taken orally under fasted and fed condition |
| OCAS-M | Experimental | Drug: YM178 modified release (OCAS), Drug: YM178 immediate release (IR)YM178 OCAS tablet (OCAS-Medium) taken orally under fasted and fed condition |
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 BMI 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 and/or abnormal serum bilirubin
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of upper gastrointestinal symptoms 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, renal, hepatic, neurological, dermatological, psychiatric or metabolic
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 |
|---|---|---|
| YM178 modified release (OCAS)Also: mirabegron, Myrebtriqoral | Drug | OCAS-F, OCAS-M, OCAS-S |
| YM178 immediate release (IR)Also: mirabegron, Myrebtriqoral | Drug | OCAS-F, OCAS-M, OCAS-S |
Primary outcome
Pharmacokinetics profile of OCAS and IR assessed by plasma concentration
Time frame: Day 1 & Day 6 - Day 8
AUC0-12h (Area under the plasma concentration - time curve from t=0 to t=12h) Cmax (Maximum concentration), tmax (Time to attain Cmax) and Ctrough (Pre-dose plasma concentration)
Pharmacokinetics profile of OCAS assessed by plasma concentration
Time frame: Day 8
AUC0-24h (Area under the plasma concentration - time curve from t=0 to t=24h) Cmax, Tmax and Ctrough
Pharmacokinetics profile of IR assessed by plasma concentration
Time frame: Day 8
AUC0-12h , AUC12-24h (Area under the plasma concentration - time curve from t=12 to t=24h), AUC0-24h, PTR (Peak trough ratio), Cmax, Tmax and Ctrough
1 secondary outcome
Monitoring of safety parameters through assessment of vital signs, adverse events, Electrocardiogram (ECG) and clinical laboratory assessments
Time frame: Baseline until Post Study Visit
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 Jul 2013.
- Background: PubMed 23497763Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014.
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 YM178 modified release (OCAS) and YM178 immediate release (IR) in people with Pharmacokinetics of YM178 and Healthy Subjects, run by Astellas Pharma Europe B.V. 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 2 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 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?
Pharmacokinetics profile of OCAS and IR assessed by plasma concentration (time frame: Day 1 & Day 6 - Day 8). 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?
On the ClinicalTrials.gov record for NCT01646294, 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 2 Jul 2013.