HealthyPhase 1NCT01394653
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake
A Phase 1 study testing YM060 in people with Healthy and Plasma Concentration of YM060, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Plasma Concentration of YM060
- What is being tested?
- YM060
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Aug 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy assessed by the principal investigator or sub-investigators
- non-smoking or stop smoking at least 90 days before the study
- body weight: over 50.0kg and less than 80.0kg
- body mass index (BMI): over 17.6 and less than 26.4
Who cannot join
- participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
- donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
- received any drugs within 7 days before the study or going to receive any drugs
- deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
- deviance from normal range in lab-tests
- history of drug allergy
Show all 14Show fewer
- history or current diagnosis of stomach, small intestine or large intestine diseases
- history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- history or current diagnosis of colitis ischemic
- history or current diagnosis of hepatic diseases
- history or current diagnosis of cardiovascular diseases
- history or current diagnosis of respiratory diseases
- history or current diagnosis of malignant tumor
- received ramosetron tablet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -
A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.
- Conditions
- Healthy, Plasma Concentration of YM060
- Being tested
- YM060
- Keywords
- YM060, ramosetron, orally-disintegrating tablet, OD tablet, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM060Drug
Also called ramosetron, Irribow
oral, with water
| Study group | Role | What they receive |
|---|---|---|
| orally-disintegrating (OD) tablet precedence group | Experimental | Not described Receives: Drug: YM060 |
| conventional tablet precedence group | Experimental | Not described Receives: Drug: YM060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of YM060 plasma concentration -time curve
Measured: up to 24 hours after administration
Maximal concentration of YM060 plasma concentration
Measured: up to 24 hours after administration
Secondary outcomes (1)
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG
Measured: up to 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394653
- Sponsor's protocol ID
- 060-CL-209
- Status last verified
- Oct 2011
- First submitted
- 11 Jul 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -
- ClinicalTrials.gov ID
- NCT01394653
- Acronym / sponsor ID
- 060-CL-209
- Conditions
- Healthy, Plasma Concentration of YM060
- Keywords
- YM060, ramosetron, orally-disintegrating tablet, OD tablet, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Jul 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 compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orally-disintegrating (OD) tablet precedence group | Experimental | Drug: YM060 |
| conventional tablet precedence group | Experimental | Drug: YM060 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy assessed by the principal investigator or sub-investigators
- non-smoking or stop smoking at least 90 days before the study
- body weight: over 50.0kg and less than 80.0kg
- body mass index (BMI): over 17.6 and less than 26.4
Key exclusion criteria (14 listed)
- participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
- donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
- received any drugs within 7 days before the study or going to receive any drugs
- deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
- deviance from normal range in lab-tests
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 |
|---|---|---|
| YM060Also: ramosetron, Irriboworal, with water | Drug | conventional tablet precedence group, orally-disintegrating (OD) tablet precedence group |
Primary outcome
Area under the curve of YM060 plasma concentration -time curve
Time frame: up to 24 hours after administration
Maximal concentration of YM060 plasma concentration
Time frame: up to 24 hours after administration
1 secondary outcome
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG
Time frame: up to 24 hours after administration
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 Oct 2011.
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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 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 YM060 in people with Healthy and Plasma Concentration of YM060, run by Astellas Pharma Inc at 1 site in Japan.
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 4 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 12 Oct 2011. 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 Japan. 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?
Area under the curve of YM060 plasma concentration -time curve (time frame: up to 24 hours after administration). 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 Oct 2011.