Drug-drug Interaction Study of FYU-981 and Oxaprozin
Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Nov 2017
Shorter than P25 for phase_1 healthy
1 active site
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
November 2, 2017
CompletedFirst Submitted
Initial submission to the registry
November 19, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2017
CompletedSeptember 14, 2022
September 1, 2022
1 month
November 19, 2017
September 9, 2022
Conditions
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 event)
20 days
Study Arms (2)
Single dose
EXPERIMENTALSingle administration of FYU-981
Concomitant administration
EXPERIMENTALConcomitant administration of FYU-981 with oxaprozin at steady state
Interventions
Eligibility Criteria
You may qualify if:
- Adult healthy subjects
- Body mass index: \>=18.5 and \<25.0
You may not qualify if:
- Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mochida Pharmaceutical Company, Ltd.lead
- Fuji Yakuhin Co., Ltd.collaborator
Study Sites (1)
P-One Clinic
Hachiōji, Tokyo, 192-0071, Japan
Related Publications (1)
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.
PMID: 32076889DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nagasawa Katsuaki
Clinical Research Department
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2017
First Posted
November 22, 2017
Study Start
November 2, 2017
Primary Completion
December 5, 2017
Study Completion
December 5, 2017
Last Updated
September 14, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share