Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
NCT ID: NCT02347046
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2015-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Moderately-decreased group
(eGFR: \>=30mL/min/1.73m\^2 and \< 60mL/min/1.73m\^2)
FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Slightly-decreased group
(eGFR: \>=60mL/min/1.73m\^2 and \< 90mL/min/1.73m\^2)
FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Normal group
(eGFR: \>=90mL/min/1.73m\^2)
FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Interventions
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FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Eligibility Criteria
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Inclusion Criteria
* Body mass index: \>=18.5 and \<30.0
Exclusion Criteria
20 Years
MALE
Yes
Sponsors
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Fuji Yakuhin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Japan
Kagoshima, , Japan
Countries
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References
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Fukase H, Okui D, Sasaki T, Fushimi M, Ohashi T, Hosoya T. Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):17-24. doi: 10.1007/s10157-019-01825-3. Epub 2019 Dec 10.
Other Identifiers
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FYU-981-005
Identifier Type: -
Identifier Source: org_study_id
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