HealthyPhase 1NCT03350373
Clinical Pharmacology of FYU-981 (Final Formulation)
A Phase 1 study testing FYU-981 in people with Healthy, run by Mochida Pharmaceutical Company, Ltd. at 1 site in Japan.
Trial summary
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 6 Nov 2017to 29 Nov 2017
- 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: Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
- Conditions
- Healthy
- Being tested
- FYU-981
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYU-981Drug
Also called Final formulation of FYU-981
Single administration of FYU-981 under Fasted and fed conditions in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | Dosing of FYU-981 in the fasted state followed by fed dosing Receives: Drug: FYU-981 |
| Fed dosing followed by fasted dosing | Experimental | Dosing of FYU-981 in the fed state followed by fasted dosing 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
Safety (Incidence of treatment-emergent adverse events)
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start6 Nov 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- Katsuaki Nagasawa, Study director, Clinical Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350373
- Sponsor's protocol ID
- FYU-981-016
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 12 Dec 2017
- 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 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults
- ClinicalTrials.gov ID
- NCT03350373
- Acronym / sponsor ID
- FYU-981-016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fuji Yakuhin Co., Ltd.
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 22 Nov 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.
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | Drug: FYU-981Dosing of FYU-981 in the fasted state followed by fed dosing |
| Fed dosing followed by fasted dosing | Experimental | Drug: FYU-981Dosing of FYU-981 in the fed state followed by fasted dosing |
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-981Also: Final formulation of FYU-981Single administration of FYU-981 under Fasted and fed conditions in the morning. | Drug | Fasted dosing followed by fed dosing, Fed dosing followed by fasted dosing |
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
Time frame: 48 hours
T1/2: Elimination half-life of plasma concentration
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
Safety (Incidence of treatment-emergent adverse events)
Time frame: 13 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 12 Dec 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Katsuaki Nagasawa 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 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 12 Dec 2017. 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 9 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 12 Dec 2017.