NCT02347046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

January 16, 2015

Last Update Submit

March 5, 2015

Conditions

Renal InsufficiencyHealthy

Outcome Measures

Primary Outcomes (10)

  • Pharmacokinetics (Cmax: Maximum plasma concentration)

    48 hours

  • Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

    48 hours

  • Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

    48 hours

  • Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

    48 hours

  • Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)

    48 hours

  • Pharmacokinetics (kel: Elimination rate constant)

    48 hours

  • Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)

    48 hours

  • Pharmacokinetics (MRT: Mean residence time)

    48 hours

  • Pharmacokinetics (Ae: Amount of drug excreted in urine)

    48 hours

  • Pharmacokinetics (fe: Fraction of dose excreted in urine)

    48 hours

Study Arms (3)

Moderately-decreased group

EXPERIMENTAL

(eGFR: \>=30mL/min/1.73m\^2 and \< 60mL/min/1.73m\^2)

Drug: FYU-981, (Oral single dosing)

Slightly-decreased group

EXPERIMENTAL

(eGFR: \>=60mL/min/1.73m\^2 and \< 90mL/min/1.73m\^2)

Drug: FYU-981, (Oral single dosing)

Normal group

EXPERIMENTAL

(eGFR: \>=90mL/min/1.73m\^2)

Drug: FYU-981, (Oral single dosing)

Interventions

FYU-981, (Oral single dosing)DRUG

FYU-981, (Oral single dosing)

Moderately-decreased groupNormal groupSlightly-decreased group

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese adult subjects
  • Body mass index: \>=18.5 and \<30.0

You may not qualify if:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Kagoshima, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31823130DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

dotinurad

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 27, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-01

Locations

JP(1)