CompletedNCT02348333Updated Jan 28, 2015

Repeated Dose Phase I Study of FYU-981

A Phase 1 interventional study of FYU-981, (Oral daily dosing for 7 days) and Placebo, (Oral daily dosing for 7 days) in Healthy, sponsored by Fuji Yakuhin Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-28.

Sponsored by Fuji Yakuhin Co., Ltd. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 20 Years to 35 Years
Sex: Male

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Fuji Yakuhin Co., Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 35 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Japanese healthy adult subjects
Body mass index: >=18.5 and \<25.0

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 18 participants (actual)

Study arms

Active comparator
FYU-981
Drug: FYU-981, (Oral daily dosing for 7 days)
Placebo comparator
Placebo
Drug: Placebo, (Oral daily dosing for 7 days)

Interventions

DrugFYU-981, (Oral daily dosing for 7 days)
Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
DrugPlacebo, (Oral daily dosing for 7 days)
Subjects randomized to the placebo arm receive placebo.

What researchers measure

Primary outcomes

Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)
Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)
Time frame: 4-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time frame: 9 days
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time frame: 9 days

Study locations

1 site

Japan
Tokyo, Japan

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2013, a primary completion of Nov 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 18, 2015
First posted: Jan 28, 2015
Start: Sep 2013
Primary completionActual: Nov 2013
CompletionActual: Dec 2013
Last update: Jan 28, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02348333
Lead sponsor: Fuji Yakuhin Co., Ltd.
Responsible party: Sponsor
First posted: Jan 28, 2015
Start date: Sep 2013
Primary completion: Nov 2013
Completion: Dec 2013
Last update: Jan 28, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dotinurad

Other studies from this sponsor

Fuji Yakuhin Co., Ltd.

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