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NCT02837198
Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
Phase 2 trial testing FYU-981 in Hyperuricemia in 24 participants. Completed in 1 March 2018.
1 August 2017
Quick facts
| Lead sponsor | Fuji Yakuhin Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 July 2016 |
| Primary completion | 1 August 2017 |
| Estimated completion | 1 March 2018 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- FYU-981 — full drug profile →
- Topiroxostat (TOPIROXOSTAT) — full drug profile →
Conditions studied
- Hyperuricemia — all drugs for Hyperuricemia →
Sponsor
Fuji Yakuhin Co., Ltd. — full company profile →
Who can join
20 and older, male only, with Hyperuricemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation
Tejero J, Shiva S, Gladwin MT. · · 2019 · cited 357× · PMID 30379623 · DOI 10.1152/physrev.00036.2017 -
Dotinurad: a novel selective urate reabsorption inhibitor as a future therapeutic option for hyperuricemia.
Kuriyama S. · · 2020 · cited 21× · PMID 31754883 · DOI 10.1007/s10157-019-01811-9 -
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.
Okui D, Sasaki T, Fushimi M, Ohashi T. · · 2020 · cited 8× · PMID 31734820 · DOI 10.1007/s10157-019-01817-3 -
Correction to: Dotinurad: a novel selective urate reabsorption inhibitor as a future therapeutic option for hyperuricemia.
Kuriyama S. · · 2020 · cited 2× · PMID 31970592 · DOI 10.1007/s10157-020-01845-4
Verify or expand the search:
- PubMed search for NCT02837198
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FYU-981
Trials testing the same drug.
- NCT03372200 — Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout · Phase 3 · completed
- NCT03375632 — Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types) · Phase 1 · completed
- NCT03350373 — Clinical Pharmacology of FYU-981 (Final Formulation) · Phase 1 · completed
- NCT03350386 — Drug-drug Interaction Study of FYU-981 and Oxaprozin · Phase 1 · completed
- NCT03306667 — Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) · Phase 1 · completed
Other recruiting trials for Hyperuricemia
Currently open trials in the same condition.
- NCT07144332 — This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Ord · recruiting
- NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
- NCT06859073 — A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia · Phase 1 · recruiting
- NCT06463561 — CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea · Phase 4 · recruiting
- NCT06729853 — PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function · Phase 1, PHASE2 · active not recruiting
Other Fuji Yakuhin Co., Ltd. trials
Trials by the same sponsor.
- NCT03345316 — Study of FFI-1010 in Pediatric Kidney Disease · Phase 3 · completed
- NCT03100318 — Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02837198 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fuji Yakuhin Co., Ltd.
- Last refreshed: 20 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02837198.
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