NCT03350373

Brief Summary

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

23 days

First QC Date

November 19, 2017

Last Update Submit

December 11, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • 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

  • Safety (Incidence of treatment-emergent adverse events)

    13 days

Study Arms (2)

Fasted dosing followed by fed dosing

EXPERIMENTAL

Dosing of FYU-981 in the fasted state followed by fed dosing

Drug: FYU-981

Fed dosing followed by fasted dosing

EXPERIMENTAL

Dosing of FYU-981 in the fed state followed by fasted dosing

Drug: FYU-981

Interventions

FYU-981DRUG

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Also known as: Final formulation of FYU-981
Fasted dosing followed by fed dosingFed dosing followed by fasted dosing

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese healthy adult subjects
  • 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)

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

MeSH Terms

Interventions

dotinurad

Study Officials

  • Katsuaki Nagasawa

    Clinical Research Department

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2017

First Posted

November 22, 2017

Study Start

November 6, 2017

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

December 12, 2017

Record last verified: 2017-11

Locations

JP(1)