Hyperuricemia With or Without GoutPhase 1NCT03375632
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
A Phase 1 study testing FYU-981 in people with Hyperuricemia With or Without Gout, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.
Trial summary
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Hyperuricemia With or Without Gout
- What is being tested?
- FYU-981
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteJapan
- Study dates
- 4 Jan 2018to 5 Jun 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum urate level:
- >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
- Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
- Outpatients
Who cannot join
- Gouty arthritis within 14 days before randomized allocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.
- Conditions
- Hyperuricemia With or Without Gout
- Being tested
- FYU-981
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981Drug
Oral daily dosing for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Uric acid-overproduction Type | Experimental | Not described Receives: Drug: FYU-981 |
| Uric acid-underexcretion Type | Experimental | Not described Receives: Drug: FYU-981 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics (Amount of uric acid excreted in urine)
Measured: 2-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Measured: 6-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Measured: 10-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Measured: 14-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start4 Jan 2018
- Primary completion29 May 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia With or Without GoutStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kazuki Furuno, Study director, Clinical Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375632
- Sponsor's protocol ID
- FYU-981-013
- Status last verified
- Sep 2018
- First submitted
- 10 Dec 2017
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
- ClinicalTrials.gov ID
- NCT03375632
- Acronym / sponsor ID
- FYU-981-013
- Conditions
- Hyperuricemia With or Without Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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.
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uric acid-overproduction Type | Experimental | Drug: FYU-981 |
| Uric acid-underexcretion Type | Experimental | Drug: FYU-981 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serum urate level:
- Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
- Outpatients
Key exclusion criteria (1 listed)
- Gouty arthritis within 14 days before randomized allocation
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-981Oral daily dosing for 14 weeks | Drug | Uric acid-overproduction Type, Uric acid-underexcretion Type |
Primary outcome
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 2-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 6-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 10-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 14-week
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 Sep 2018.
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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.
Kazuki Furuno study director
Clinical Research Department
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 FYU-981 in people with Hyperuricemia With or Without Gout, run by Mochida Pharmaceutical Company, 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 4 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 24 Sep 2018. 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?
Pharmacodynamics (Amount of uric acid excreted in urine) (time frame: 2-week). The study lists 4 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 24 Sep 2018.