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CompletedNCT03350386Updated Sep 14, 2022

Drug-drug Interaction Study of FYU-981 and Oxaprozin

A Phase 1 interventional study of FYU-981 and Oxaprozin in Healthy, sponsored by Mochida Pharmaceutical Company, 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 2022-09-14.

Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Mochida Pharmaceutical Company, 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.

04

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

  • Adult healthy subjects
  • : >=18.5 and \<25.0

Exclusion criteria

Exclusion Criteria:

  • Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Single dose

    Single administration of FYU-981

    Drug: FYU-981

  • Experimental
    Concomitant administration

    Concomitant administration of FYU-981 with oxaprozin at steady state

    Drug: FYU-981 · Drug: Oxaprozin

Interventions

  • DrugFYU-981

    Single administration

  • DrugOxaprozin

    Repeated administration

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

  6. Pharmacokinetics (kel: Elimination rate constant)

    Time frame: 48 hours

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

    Time frame: 48 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Time frame: 48 hours

  9. Safety (Incidence of treatment-emergent adverse event)

    Time frame: 20 days

07

Study locations

1 site
  • P-One Clinic
    Hachiōji, Tokyo 192-0071, Japan
08

References and documents

Publications

  • Furihata K, Nagasawa K, Hagino A, Kumagai Y. A drug-drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):36-43. doi: 10.1007/s10157-020-01855-2. Epub 2020 Feb 19. PubMed 32076889 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Dec 2017, 1 month.

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

Registered
Nov 19, 2017
First posted
Nov 22, 2017
StartActual
Nov 2, 2017
Primary completionActual
Dec 5, 2017
CompletionActual
Dec 5, 2017
Last update
Sep 14, 2022
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 Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03350386
Lead sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Nov 2, 2017
Primary completion
Dec 5, 2017
Completion
Dec 5, 2017
Last update
Sep 14, 2022

Study contacts

Nagasawa Katsuaki
study director · Clinical Research Department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. 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

Mochida Pharmaceutical Company, Ltd.

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