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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
Fuji Yakuhin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Insufficiency

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

First Posted
January 16, 2015
Last Updated
March 5, 2015
Sponsor
Fuji Yakuhin Co., Ltd.
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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

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Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

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