Functional DyspepsiaPhase 1NCT00850746
A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults
A Phase 1 study testing YM443 and Moxifloxacin in people with Functional Dyspepsia, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- YM443 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male or non pregnant, non lactating female
- Weighing at least 45 kg
- Body Mass Index (BMI) between 18 and 32 kg/m2
Who cannot join
- The subject has evidence of any cardiac conduction abnormalities
- The subject has a previous history of any medical or psychiatric condition that would preclude participation in the study
- The subject has participated in another clinical trial in the last 30 days
- The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM443 on Day 1 of Period 1 and throughout the duration of the study
- The subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to Screening
- The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within 2 years prior to Screening
- The subject has donated any whole blood or cellular blood component or has undergone significant loss of blood or has received transfusion of any blood or blood products within 56 days of Day -1 of Period 1 or has donated plasma within 7 days of Day -1 of Period 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Active- Controlled, Crossover Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Male and Female Adult Subjects
This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.
Read the detailed description
Each subject participates in all four treatment periods separated by washout periods.
In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.
- Conditions
- Functional Dyspepsia
- Being tested
- YM443, Placebo, Moxifloxacin
- Keywords
- QT interval, Cardiac Repolarization, Cardiac Conduction, Healthy Subjects, YM443 (Z-338, acotiamide hydrochloride), Evaluation of QT Interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM443Drug
Also called Z-338, acotiamide hydrochloride
Oral
PlaceboDrug
Oral
MoxifloxacinDrug
Also called Avelox
Oral
| Study group | Role | What they receive |
|---|---|---|
| A. Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| B. Ym443 Lower Dose | Experimental | Not described Receives: Drug: YM443 |
| C. YM443 Higher Dose | Experimental | Not described Receives: Drug: YM443 |
| D. Moxiflocxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
Measured: Following four days of dosing
Secondary outcomes (3)
The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.
Measured: Following four days of dosing
The pharmacokinetics of YM443 in these subjects
Measured: Day 5
The safety and tolerability of YM443
Measured: Following four days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850746
- Sponsor's protocol ID
- 443-CL-048
- Status last verified
- Mar 2014
- First submitted
- 23 Feb 2009
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo- and Active- Controlled, Crossover Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Male and Female Adult Subjects
- ClinicalTrials.gov ID
- NCT00850746
- Acronym / sponsor ID
- 443-CL-048
- Conditions
- Functional Dyspepsia
- Keywords
- QT interval, Cardiac Repolarization, Cardiac Conduction, Healthy Subjects, YM443 (Z-338, acotiamide hydrochloride), Evaluation of QT Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Feb 2009 (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.
This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.
Detailed description
Each subject participates in all four treatment periods separated by washout periods.
In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. Placebo | Placebo comparator | Drug: Placebo |
| B. Ym443 Lower Dose | Experimental | Drug: YM443 |
| C. YM443 Higher Dose | Experimental | Drug: YM443 |
| D. Moxiflocxacin | Active comparator | Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Male or non pregnant, non lactating female
- Weighing at least 45 kg
- Body Mass Index (BMI) between 18 and 32 kg/m2
Key exclusion criteria (7 listed)
- The subject has evidence of any cardiac conduction abnormalities
- The subject has a previous history of any medical or psychiatric condition that would preclude participation in the study
- The subject has participated in another clinical trial in the last 30 days
- The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM443 on Day 1 of Period 1 and throughout the duration of the study
- The subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to Screening
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 |
|---|---|---|
| YM443Also: Z-338, acotiamide hydrochlorideOral | Drug | B. Ym443 Lower Dose, C. YM443 Higher Dose |
| PlaceboOral | Drug | A. Placebo |
| MoxifloxacinAlso: AveloxOral | Drug | D. Moxiflocxacin |
Primary outcome
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
Time frame: Following four days of dosing
3 secondary outcomes
The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.
Time frame: Following four days of dosing
The pharmacokinetics of YM443 in these subjects
Time frame: Day 5
The safety and tolerability of YM443
Time frame: Following four days of 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 24 Mar 2014.
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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 director
Astellas Pharma Global Development
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 YM443 and Moxifloxacin in people with Functional Dyspepsia, run by Astellas Pharma Inc at 1 site in United States.
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 7 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 24 Mar 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo (time frame: Following four days of dosing). 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 24 Mar 2014.