NCT02348333

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

January 18, 2015

Last Update Submit

January 22, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

  • Pharmacokinetics (Cmax: Maximum plasma concentration)

    1-, 4-, and 7-day

  • Pharmacokinetics (Cmin: Minimum plasma concentration)

    1-, 2-, 3-, 4-, 5-, 6- and 7-day

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

    1-, 4-, and 7-day

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

    1-, 4-, and 7-day

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

    1-, 4-, and 7-day

  • Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)

    4-, and 7-day

  • Pharmacokinetics (kel: Elimination rate constant)

    1-, 4-, and 7-day

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

    1-, 4-, and 7-day

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

    9 days

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

    9 days

Study Arms (2)

FYU-981

ACTIVE COMPARATOR
Drug: FYU-981, (Oral daily dosing for 7 days)

Placebo

PLACEBO COMPARATOR
Drug: Placebo, (Oral daily dosing for 7 days)

Interventions

FYU-981, (Oral daily dosing for 7 days)DRUG

Subjects randomized to the FYU-981 arm receive active drug, FYU-981.

FYU-981
Placebo, (Oral daily dosing for 7 days)DRUG

Subjects randomized to the placebo arm receive placebo.

Placebo

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)

Japan

Tokyo, Japan

Location

MeSH Terms

Interventions

dotinurad

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2015

First Posted

January 28, 2015

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

JP(1)