NCT02344875

Brief Summary

The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1 healthy

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

May 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

January 18, 2015

Last Update Submit

January 22, 2015

Conditions

Healthy

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 (4)

Male elder subjects

EXPERIMENTAL

Male 65- Years

Drug: FYU-981, (Oral single dosing)

Male non-elder subjects

EXPERIMENTAL

Male 20-35 Years

Drug: FYU-981, (Oral single dosing)

Female elder subjects

EXPERIMENTAL

Female 65- Years

Drug: FYU-981, (Oral single dosing)

Female non-elder subjects

EXPERIMENTAL

Female 20-35 Years

Drug: FYU-981, (Oral single dosing)

Interventions

FYU-981, (Oral single dosing)DRUG
Female elder subjectsFemale non-elder subjectsMale elder subjectsMale non-elder subjects

Eligibility Criteria

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

You may qualify if:

  • Japanese adult subjects
  • Years (non-elder groups)
  • Years (elder groups)
  • Body mass index: \>=18.5 and \<25.0

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

Tokyo, Japan

Location

Related Publications (1)

  • Nakatani H, Fushimi M, Sasaki T, Okui D, Ohashi T. Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):8-16. doi: 10.1007/s10157-019-01836-0. Epub 2019 Dec 30.

    PMID: 31889230DERIVED

MeSH Terms

Interventions

dotinurad

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 18, 2015

First Posted

January 26, 2015

Study Start

May 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

JP(1)