Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
Primary Purpose
Renal Insufficiency, Healthy
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
FYU-981, (Oral single dosing)
Sponsored by
About this trial
This is an interventional basic science trial for Renal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Japanese adult subjects
- Body mass index: >=18.5 and <30.0
Exclusion Criteria:
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderately-decreased group
Slightly-decreased group
Normal group
Arm Description
(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2)
(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2)
(eGFR: >=90mL/min/1.73m^2)
Outcomes
Primary Outcome Measures
Pharmacokinetics (Cmax: Maximum plasma concentration)
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Pharmacokinetics (kel: Elimination rate constant)
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Pharmacokinetics (MRT: Mean residence time)
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02347046
Brief Title
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
Official Title
Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Yakuhin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderately-decreased group
Arm Type
Experimental
Arm Description
(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2)
Arm Title
Slightly-decreased group
Arm Type
Experimental
Arm Description
(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2)
Arm Title
Normal group
Arm Type
Experimental
Arm Description
(eGFR: >=90mL/min/1.73m^2)
Intervention Type
Drug
Intervention Name(s)
FYU-981, (Oral single dosing)
Intervention Description
FYU-981, (Oral single dosing)
Primary Outcome Measure Information:
Title
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame
48 hours
Title
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame
48 hours
Title
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame
48 hours
Title
Pharmacokinetics (kel: Elimination rate constant)
Time Frame
48 hours
Title
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame
48 hours
Title
Pharmacokinetics (MRT: Mean residence time)
Time Frame
48 hours
Title
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time Frame
48 hours
Title
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time Frame
48 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Japanese adult subjects
Body mass index: >=18.5 and <30.0
Exclusion Criteria:
Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Facility Information:
Facility Name
Japan
City
Kagoshima
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31823130
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
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