HyperuricemiaPhase 2NCT02837198
Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
A Phase 2 study testing FYU-981 and Topiroxostat in people with Hyperuricemia, run by Fuji Yakuhin Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- FYU-981 and Topiroxostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2016to Mar 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese adult subjects
- Serum urate level: >= 7.0mg/dL in patients
- Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type
Who cannot join
- Gouty arthritis within a year before start of study treatment
- Mixed type in the classification of hyperuricemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.
In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.
- Conditions
- Hyperuricemia
- Being tested
- FYU-981, Topiroxostat
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981Drug
TopiroxostatDrug
Also called FYX-051
| Study group | Role | What they receive |
|---|---|---|
| Uric acid-overproduction Type | Experimental | FYU-981 Receives: Drug: FYU-981 |
| Uric acid- underexcretion Type | Experimental | FYU-981 Receives: Drug: FYU-981 |
| Uric acid-overproduction Type (combination) | Experimental | FYU-981 , Topiroxostat Receives: Drug: FYU-981; Drug: Topiroxostat |
| Uric acid- underexcretion Type2 | Experimental | FYU-981 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: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Pharmacodynamics (Renal clearance of uric acid)
Measured: 1-, 4- and 7-day
Pharmacodynamics (Fractional uric acid excretion)
Measured: 4- and 7-day
Pharmacodynamics (Maximum delta effective uric acid concentration)
Measured: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
Measured: 1-, 4- and 7-day
Secondary outcomes (9)
Pharmacokinetics (Cmax: Maximum plasma concentration)
Measured: 1-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)
Measured: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Measured: 1-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Measured: 1-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Measured: 1-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Measured: 1-, and 7-day
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Measured: 1-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Measured: 1-, and 7-day
Pharmacokinetics (MRT: Mean residence time)
Measured: 1-, and 7-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionMar 2018
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 HyperuricemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02837198
- Sponsor's protocol ID
- FYU-981-008
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16.
PubMed 31734820
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
- ClinicalTrials.gov ID
- NCT02837198
- Acronym / sponsor ID
- FYU-981-008
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fuji Yakuhin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Jul 2016 (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.
To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.
In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Uric acid-overproduction Type | Experimental | Drug: FYU-981FYU-981 |
| Uric acid- underexcretion Type | Experimental | Drug: FYU-981FYU-981 |
| Uric acid-overproduction Type (combination) | Experimental | Drug: FYU-981, Drug: TopiroxostatFYU-981 , Topiroxostat |
| Uric acid- underexcretion Type2 | Experimental | Drug: FYU-981FYU-981 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese adult subjects
- Serum urate level: >= 7.0mg/dL in patients
- Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type
Key exclusion criteria (2 listed)
- Gouty arthritis within a year before start of study treatment
- Mixed type in the classification of hyperuricemia
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 | Uric acid- underexcretion Type, Uric acid- underexcretion Type2, Uric acid-overproduction Type, Uric acid-overproduction Type (combination) |
| TopiroxostatAlso: FYX-051 | Drug | Uric acid-overproduction Type (combination) |
Primary outcome
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Pharmacodynamics (Renal clearance of uric acid)
Time frame: 1-, 4- and 7-day
Pharmacodynamics (Fractional uric acid excretion)
Time frame: 4- and 7-day
Pharmacodynamics (Maximum delta effective uric acid concentration)
Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
Time frame: 1-, 4- and 7-day
9 secondary outcomes
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 1-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)
Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 1-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 1-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 1-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 1-, and 7-day
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 1-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 1-, and 7-day
Pharmacokinetics (MRT: Mean residence time)
Time frame: 1-, and 7-day
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 21 Aug 2018.
- Derived from this study: PubMed 31734820Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16.
- Individual participant dataSharing planned: No
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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 Topiroxostat in people with Hyperuricemia, 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 3 inclusion and 2 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 21 Aug 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 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?
Pharmacodynamics (Amount of uric acid excreted in urine) (time frame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day). The study lists 5 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 NCT02837198, 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 21 Aug 2018.