AzTrials
AzTrials

Healthy Male SubjectsPhase 2NCT02901366

Mass Balance Study of FYU-981

A Phase 2 study testing 14C-FYU-981 in people with Healthy Male Subjects, run by Fuji Yakuhin Co., 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
Search all trials

Trial summary

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects. 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 Male Subjects
What is being tested?
14C-FYU-981
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteJapan
Study dates
Sep 2016to Jul 2018
Phase
Phase 2
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

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

Who cannot join

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
  • Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
  • Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
  • Occupationally exposed worker

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Tokyo

Other trials in Japan

About this study

Official title: Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

Being tested
14C-FYU-981
Keywords
Mass balance

What participants receive

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

  • 14C-FYU-981Drug

    14C-FYU-981, (Oral single dosing)

Study groups in NCT02901366
Study groupRoleWhat they receive
14C-FYU-981Experimental14C-FYU-981, (Oral single dosing)
Receives: Drug: 14C-FYU-981

What is being measured

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

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Measured: 168 hours

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

    Measured: 168 hours

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

    Measured: 168 hours

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

    Measured: 168 hours

  5. Pharmacokinetics (kel: Elimination rate constant)

    Measured: 168 hours

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

    Measured: 168 hours

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

    Measured: 168 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Measured: 168 hours

  9. Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)

    Measured: 168 hours or 72 hours (Ae(air))

  10. Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)

    Measured: 168 hours or 72 hours (Ae(air))

  11. Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)

    Measured: 168 hours

  12. Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)

    Measured: 168 hours

  13. Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)

    Measured: 168 hours

  14. Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)

    Measured: 168 hours

  15. Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)

    Measured: 168 hours

Timeline

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

  1. First posted15 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2017
  4. Study completionJul 2018

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 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901366
Sponsor's protocol ID
FYU-981-009
Status last verified
Aug 2018
First submitted
12 Sep 2016
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 14C-FYU-981 in people with Healthy Male Subjects, run by Fuji Yakuhin Co., 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 4 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 21 Aug 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: 168 hours). The study lists 15 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 NCT02901366.

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 21 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in