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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

Who can participate

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

Inclusion criteria

  • Adult healthy subjects
  • Body mass index: >=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
04

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

05

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

06

Study locations

1 site
  • P-One Clinic
    Hachiōji, Tokyo 192-0071, Japan
07

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

08

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 ↗

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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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