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HealthyPhase 1NCT03350386

Drug-drug Interaction Study of FYU-981 and Oxaprozin

A Phase 1 study testing FYU-981 and Oxaprozin in people with Healthy, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
FYU-981 and Oxaprozin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteJapan
Study dates
2 Nov 2017to 5 Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • P-One Clinic

    Hachiōji, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: 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.

Conditions
Healthy
Being tested
FYU-981, Oxaprozin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FYU-981Drug

    Single administration

  • OxaprozinDrug

    Repeated administration

Study groups in NCT03350386
Study groupRoleWhat they receive
Single doseExperimentalSingle administration of FYU-981
Receives: Drug: FYU-981
Concomitant administrationExperimentalConcomitant administration of FYU-981 with oxaprozin at steady state
Receives: Drug: FYU-981; Drug: Oxaprozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Measured: 48 hours

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

    Measured: 48 hours

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

    Measured: 48 hours

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

    Measured: 48 hours

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

    Measured: 48 hours

  6. Pharmacokinetics (kel: Elimination rate constant)

    Measured: 48 hours

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

    Measured: 48 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Measured: 48 hours

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

    Measured: 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start2 Nov 2017
  3. Primary completion5 Dec 2017
  4. Study completion5 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350386
Sponsor's protocol ID
FYU-981-017
Status last verified
Sep 2022
First submitted
19 Nov 2017
Last updated
14 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FYU-981 and Oxaprozin in people with Healthy, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (Cmax: Maximum plasma concentration) (time frame: 48 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350386, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

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