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CompletedNCT03306667Updated Sep 24, 2018

Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

A Phase 1 interventional study of FYU-981 in Hepatic Insufficiency and Healthy, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

02

Conditions studied

  • Hepatic Insufficiency
  • Healthy

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03

In context

Hepatic Insufficiency

113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.

This study's enrollment of 24 is below the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult healthy subjects or adult cirrhosis patients
  • : >=18.5 and \<30.0

Exclusion criteria

Exclusion Criteria:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Normal group

    Healthy control subjects

    Drug: FYU-981

  • Experimental
    Mild hepatic-insufficient group

    Patients with mild hepatic impaired function (Child-Pugh A)

    Drug: FYU-981

  • Experimental
    Moderate hepatic-insufficient group

    Patients with moderate hepatic impaired function (Child-Pugh B)

    Drug: FYU-981

  • Experimental
    Severe hepatic-insufficient group

    Patients with severe hepatic impaired function (Child-Pugh C)

    Drug: FYU-981

Interventions

06

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. Pharmacodynamics (Serum concentration of uric acid)

    Time frame: 48 hours

  10. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 48 hours

  11. Safety (Incidence of treatment-emergent adverse events)

    Time frame: 192 hours

07

Study locations

1 site
  • Mochida Investigational sites
    Tokyo, Japan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2018, 8 months.

Of 38 industry-sponsored phase 1 interventional studies under Hepatic Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 8 months is close to that.

Counting every sponsor, half of 41 studies reached it within 8 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Oct 11, 2017
StartActual
Oct 6, 2017
Primary completionActual
Jun 20, 2018
CompletionActual
Jun 25, 2018
Last update
Sep 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03306667
Lead sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Oct 6, 2017
Primary completion
Jun 20, 2018
Completion
Jun 25, 2018
Last update
Sep 24, 2018

Study contacts

Shigeki Matsumoto
study director · Clinical Research Department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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