HealthyPhase 2NCT02515864
Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)
A Phase 2 study testing FYU-981 and Moxifloxacin in people with Healthy, run by Fuji Yakuhin Co., Ltd. at 1 site in Japan.
Trial summary
A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FYU-981 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2015to Nov 2016
- Phase
- Phase 2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese adult subjects
- Body mass index: >=18.5 and <27.5
Who cannot join
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers
A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.
- Conditions
- Healthy
- Being tested
- FYU-981, Placebo, Moxifloxacin, Moxifloxacin Placebo
- Keywords
- Male and Female Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981Drug
PlaceboDrug
MoxifloxacinDrug
Moxifloxacin PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| FYU-981 anticipated therapeutic dose | Experimental | Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) Receives: Drug: FYU-981; Drug: Placebo; Drug: Moxifloxacin Placebo |
| FYU-981 supratherapeutic dose | Experimental | Drug: FYU-981, Moxifloxacin Placebo (Oral) Receives: Drug: FYU-981; Drug: Moxifloxacin Placebo |
| Placebo | Placebo comparator | Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral) Receives: Drug: Placebo; Drug: Moxifloxacin Placebo |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin, FYU-981 Placebo (Oral) Receives: Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT/QTc Interval
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionNov 2016
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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuji Yakuhin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515864
- Sponsor's protocol ID
- FYU-981-007
- Status last verified
- Sep 2017
- First submitted
- 29 Jul 2015
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02515864
- Acronym / sponsor ID
- FYU-981-007
- Conditions
- Healthy
- Keywords
- Male and Female Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fuji Yakuhin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Aug 2015 (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 Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FYU-981 anticipated therapeutic dose | Experimental | Drug: FYU-981, Drug: Placebo, Drug: Moxifloxacin PlaceboDrug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) |
| FYU-981 supratherapeutic dose | Experimental | Drug: FYU-981, Drug: Moxifloxacin PlaceboDrug: FYU-981, Moxifloxacin Placebo (Oral) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Moxifloxacin PlaceboDrug: FYU-981 Placebo, Moxifloxacin Placebo (Oral) |
| Moxifloxacin | Active comparator | Drug: Placebo, Drug: MoxifloxacinDrug: Moxifloxacin, FYU-981 Placebo (Oral) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Japanese adult subjects
- Body mass index: >=18.5 and <27.5
Key exclusion criteria (1 listed)
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical 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 |
|---|---|---|
| FYU-981 | Drug | FYU-981 anticipated therapeutic dose, FYU-981 supratherapeutic dose |
| Placebo | Drug | FYU-981 anticipated therapeutic dose, Moxifloxacin, Placebo |
| Moxifloxacin | Drug | Moxifloxacin |
| Moxifloxacin Placebo | Drug | FYU-981 anticipated therapeutic dose, FYU-981 supratherapeutic dose, Placebo |
Primary outcome
QT/QTc Interval
Time frame: 24 hours
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 8 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FYU-981 and Moxifloxacin in people with Healthy, run by Fuji Yakuhin Co., Ltd. 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 2 inclusion and 1 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 8 Sep 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
QT/QTc Interval (time frame: 24 hours). 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 8 Sep 2017.