Hepatic InsufficiencyPhase 1NCT03306667
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
A Phase 1 study testing FYU-981 in people with Hepatic Insufficiency and Healthy, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency, Healthy
- What is being tested?
- FYU-981
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 6 Oct 2017to 25 Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthy subjects or adult cirrhosis patients
- Body mass index: >=18.5 and <30.0
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
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.
- Conditions
- Hepatic Insufficiency, Healthy
- Being tested
- FYU-981
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981Drug
Oral single dosing
| Study group | Role | What they receive |
|---|---|---|
| Normal group | Experimental | Healthy control subjects Receives: Drug: FYU-981 |
| Mild hepatic-insufficient group | Experimental | Patients with mild hepatic impaired function (Child-Pugh A) Receives: Drug: FYU-981 |
| Moderate hepatic-insufficient group | Experimental | Patients with moderate hepatic impaired function (Child-Pugh B) Receives: Drug: FYU-981 |
| Severe hepatic-insufficient group | Experimental | Patients with severe hepatic impaired function (Child-Pugh C) Receives: Drug: FYU-981 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax: Maximum plasma concentration)
Measured: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Measured: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Measured: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Measured: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Measured: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Measured: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Measured: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Measured: 48 hours
Pharmacodynamics (Serum concentration of uric acid)
Measured: 48 hours
Pharmacodynamics (Amount of uric acid excreted in urine)
Measured: 48 hours
Safety (Incidence of treatment-emergent adverse events)
Measured: 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start6 Oct 2017
- Primary completion20 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Shigeki Matsumoto, Study director, Clinical Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306667
- Sponsor's protocol ID
- FYU-981-015
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2017
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT03306667
- Acronym / sponsor ID
- FYU-981-015
- Conditions
- Hepatic Insufficiency, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal group | Experimental | Drug: FYU-981Healthy control subjects |
| Mild hepatic-insufficient group | Experimental | Drug: FYU-981Patients with mild hepatic impaired function (Child-Pugh A) |
| Moderate hepatic-insufficient group | Experimental | Drug: FYU-981Patients with moderate hepatic impaired function (Child-Pugh B) |
| Severe hepatic-insufficient group | Experimental | Drug: FYU-981Patients with severe hepatic impaired function (Child-Pugh C) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult healthy subjects or adult cirrhosis patients
- Body mass index: >=18.5 and <30.0
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FYU-981Oral single dosing | Drug | Mild hepatic-insufficient group, Moderate hepatic-insufficient group, Normal group, Severe hepatic-insufficient group |
Primary outcome
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time frame: 48 hours
Pharmacodynamics (Serum concentration of uric acid)
Time frame: 48 hours
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 48 hours
Safety (Incidence of treatment-emergent adverse events)
Time frame: 192 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeki Matsumoto study director
Clinical Research Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FYU-981 in people with Hepatic Insufficiency and 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 24 Sep 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 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 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2018.