HealthyPhase 1NCT02348333
Repeated Dose Phase I Study of FYU-981
A Phase 1 study testing FYU-981, (Oral daily dosing for 7 days) in people with Healthy, run by Fuji Yakuhin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. 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, (Oral daily dosing for 7 days)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Dec 2013
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.
- Conditions
- Healthy
- Being tested
- FYU-981, (Oral daily dosing for 7 days), Placebo, (Oral daily dosing for 7 days)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981, (Oral daily dosing for 7 days)Drug
Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
Placebo, (Oral daily dosing for 7 days)Drug
Subjects randomized to the placebo arm receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| FYU-981 | Active comparator | Not described Receives: Drug: FYU-981, (Oral daily dosing for 7 days) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo, (Oral daily dosing for 7 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax: Maximum plasma concentration)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)
Measured: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)
Measured: 4-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Measured: 1-, 4-, and 7-day
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Measured: 9 days
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT02348333
- Sponsor's protocol ID
- FYU-981-002
- Status last verified
- Jan 2015
- First submitted
- 18 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
- ClinicalTrials.gov ID
- NCT02348333
- Acronym / sponsor ID
- FYU-981-002
- Conditions
- 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
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 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 safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FYU-981 | Active comparator | Drug: FYU-981, (Oral daily dosing for 7 days) |
| Placebo | Placebo comparator | Drug: Placebo, (Oral daily dosing for 7 days) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Japanese healthy adult subjects
- Body mass index: >=18.5 and <25.0
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 daily dosing for 7 days)Subjects randomized to the FYU-981 arm receive active drug, FYU-981. | Drug | FYU-981 |
| Placebo, (Oral daily dosing for 7 days)Subjects randomized to the placebo arm receive placebo. | Drug | Placebo |
Primary outcome
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)
Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)
Time frame: 4-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 1-, 4-, and 7-day
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time frame: 9 days
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time frame: 9 days
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 28 Jan 2015.
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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 daily dosing for 7 days) in people with 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 28 Jan 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. Some participants in this study may receive a placebo. 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: 1-, 4-, and 7-day). 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?
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 28 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.