Healthy VolunteersPhase 1NCT04451083
Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
A Phase 1 study testing FOY-305 in people with Healthy Volunteers, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FOY-305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2020to 17 Aug 2020
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy adult male subjects
- Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
- BMI (at the time of screening test): ≥18.5 kg/m2, <25.0 kg/m2
Who cannot join
- Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- Subjects with current or with a history of severe allergy to drugs or foods
- Subjects with current or with a history of drug or alcohol abuse
- Subjects with a history of hypersensitivity caused by ingredients of this drug
Trial locations and contacts
1 site in 1 country.
About this study
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.
- Conditions
- Healthy Volunteers
- Being tested
- FOY-305
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOY-305Drug
Multiple-dose of FOY-305 will be administered orally at 4 times/day.
| Study group | Role | What they receive |
|---|---|---|
| FOY-305 | Experimental | Not described Receives: Drug: FOY-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events [Safety and Tolerability]
Number of participants with adverse events as assessed by CTCAE v5.0
Measured: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of blood pressure
Measured: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of pulse rate
Measured: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of SpO2
Measured: Up to 10 days
Body temperature [Safety and Tolerability]
Summary statistics of body temperature
Measured: Up to 10 days
Body weight [Safety and Tolerability]
Summary statistics of body weight
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (Heart Rate)
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (RR)
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (PR)
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QRS)
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QT)
Measured: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QTcF)
Measured: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (hematologic test)
Measured: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (blood biochemistry test)
Measured: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (blood coagulation test)
Measured: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (urinalysis)
Measured: Up to 10 days
Secondary outcomes (7)
Cmax of FOY-251 [Pharmacokinetic]
Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
Tmax of FOY-251 [Pharmacokinetic]
Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 day
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
T1/2 of FOY-251 [Pharmacokinetic]
Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
CL/F of FOY-251 [Pharmacokinetic]
Assessment of the CL of FOY-251 (Active metabolite of FOY-305)
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jul 2020
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susumu Nakade, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451083
- Sponsor's protocol ID
- FOY-305-02
- Status last verified
- Apr 2024
- First submitted
- 21 Jun 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT04451083
- Acronym / sponsor ID
- FOY-305-02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 30 Jun 2020 (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.
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOY-305 | Experimental | Drug: FOY-305 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese healthy adult male subjects
- Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
- BMI (at the time of screening test): ≥18.5 kg/m2, <25.0 kg/m2
Key exclusion criteria (4 listed)
- Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- Subjects with current or with a history of severe allergy to drugs or foods
- Subjects with current or with a history of drug or alcohol abuse
- Subjects with a history of hypersensitivity caused by ingredients of this drug
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 |
|---|---|---|
| FOY-305Multiple-dose of FOY-305 will be administered orally at 4 times/day. | Drug | FOY-305 |
Primary outcome
Adverse events [Safety and Tolerability]
Time frame: Up to 10 days
Number of participants with adverse events as assessed by CTCAE v5.0
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of blood pressure
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of pulse rate
Vital sign [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of SpO2
Body temperature [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of body temperature
Body weight [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of body weight
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (Heart Rate)
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (RR)
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (PR)
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QRS)
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QT)
ECG parameter test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of ECG parameter test (QTcF)
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (hematologic test)
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (blood biochemistry test)
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (blood coagulation test)
Laboratory test [Safety and Tolerability]
Time frame: Up to 10 days
Summary statistics of laboratory test (urinalysis)
7 secondary outcomes
Cmax of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
Tmax of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 day
AUC of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
T1/2 of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 days
CL/F of FOY-251 [Pharmacokinetic]
Time frame: Up to 10 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 9 Apr 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Susumu Nakade study director
Ono Pharmaceutical Co., Ltd.
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 FOY-305 in people with Healthy Volunteers, run by Ono Pharmaceutical 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 3 inclusion and 4 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 9 Apr 2024. 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?
Adverse events [Safety and Tolerability] (time frame: Up to 10 days). The study lists 16 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 9 Apr 2024.