Renal InsufficiencyPhase 1NCT02347046
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)
A Phase 1 study testing FYU-981, (Oral single dosing) in people with Renal Insufficiency and Healthy, run by Fuji Yakuhin Co., 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 renal insufficiency and with normal renal function. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Healthy
- What is being tested?
- FYU-981, (Oral single dosing)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Mar 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese adult subjects
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.
- Conditions
- Renal Insufficiency, Healthy
- Being tested
- FYU-981, (Oral single dosing)
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981, (Oral single dosing)Drug
FYU-981, (Oral single dosing)
| Study group | Role | What they receive |
|---|---|---|
| Moderately-decreased group | Experimental | (eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2) Receives: Drug: FYU-981, (Oral single dosing) |
| Slightly-decreased group | Experimental | (eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2) Receives: Drug: FYU-981, (Oral single dosing) |
| Normal group | Experimental | (eGFR: >=90mL/min/1.73m^2) Receives: Drug: FYU-981, (Oral single dosing) |
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
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Measured: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuji Yakuhin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347046
- Sponsor's protocol ID
- FYU-981-005
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
Publications
Fukase H, Okui D, Sasaki T, Fushimi M, Ohashi T, Hosoya T. Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):17-24. doi: 10.1007/s10157-019-01825-3. Epub 2019 Dec 10.
PubMed 31823130
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.
- ClinicalTrials.gov ID
- NCT02347046
- Acronym / sponsor ID
- FYU-981-005
- Conditions
- Renal Insufficiency, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fuji Yakuhin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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 renal insufficiency and with normal renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderately-decreased group | Experimental | Drug: FYU-981, (Oral single dosing)(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2) |
| Slightly-decreased group | Experimental | Drug: FYU-981, (Oral single dosing)(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2) |
| Normal group | Experimental | Drug: FYU-981, (Oral single dosing)(eGFR: >=90mL/min/1.73m^2) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese adult subjects
- 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
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-981, (Oral single dosing)FYU-981, (Oral single dosing) | Drug | Moderately-decreased group, Normal group, Slightly-decreased 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
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time frame: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time frame: 48 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 6 Mar 2015.
- Derived from this study: PubMed 31823130Fukase H, Okui D, Sasaki T, Fushimi M, Ohashi T, Hosoya T. Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):17-24. doi: 10.1007/s10157-019-01825-3. Epub 2019 Dec 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, (Oral single dosing) in people with Renal Insufficiency and Healthy, 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 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 6 Mar 2015. 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 10 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 NCT02347046, 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 6 Mar 2015.