Drug-drug Interaction Study of FYU-981 and Oxaprozin

September 9, 2022 updated by: Mochida Pharmaceutical Company, Ltd.

Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Hachiōji, Tokyo, Japan, 192-0071
        • P-One Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Adult healthy subjects
  • Body mass index: >=18.5 and <25.0

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose
Single administration of FYU-981
Drug: FYU-981
Single administration
Experimental: Concomitant administration
Concomitant administration of FYU-981 with oxaprozin at steady state
Drug: FYU-981
Single administration
Drug: Oxaprozin
Repeated administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 48 hours
48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 48 hours
48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 48 hours
48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 48 hours
48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame: 48 hours
48 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 48 hours
48 hours
Safety (Incidence of treatment-emergent adverse event)
Time Frame: 20 days
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mochida Pharmaceutical Company, Ltd.

Collaborators

Fuji Yakuhin Co., Ltd.

Investigators

  • Study Director: Nagasawa Katsuaki, Clinical Research Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

December 5, 2017

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 19, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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