Healthy VolunteersPhase 1NCT04504760
Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
A Phase 1 study testing ONO-2910 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 and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ONO-2910
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jul 2020to 18 Mar 2021
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese healthy adult male subjects (Part A and C)
- Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
- Caucasian healthy adult male subjects (Part D)
- Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)
Who cannot join
- Subjects currently with or with a history of 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.
Read the detailed description
This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.
- Conditions
- Healthy Volunteers
- Being tested
- ONO-2910, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2910Drug
Single ascending dose of ONO-2910 will be administered orally.
PlaceboDrug
Single dose of placebo will be administered orally.
ONO-2910Drug
Multiple ascending dose of ONO-2910 will be administered orally.
PlaceboDrug
Multiple dose of placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| ONO-2910 (Part A and B) | Experimental | Not described Receives: Drug: ONO-2910 |
| Placebo (Part A) | Placebo comparator | Not described Receives: Drug: Placebo |
| ONO-2910 (Part C and D) | Experimental | Not described Receives: Drug: ONO-2910 |
| Placebo (Part C and D) | Placebo comparator | Not described Receives: Drug: Placebo |
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 13 days
Secondary outcomes (9)
Cmax [Pharmacokinetic]
Assessment of the Cmax of ONO-2910
Measured: Up to 10 days
Tmax [Pharmacokinetic]
Assessment of the Tmax of ONO-2910
Measured: Up to 10 days
AUC24h [Pharmacokinetic]
Assessment of the AUC24h of ONO-2910
Measured: Up to 10 days
AUClast [Pharmacokinetic]
Assessment of the AUClast of ONO-2910
Measured: Up to 10 days
AUCinf [Pharmacokinetic]
Assessment of the AUCinf of ONO-2910
Measured: Up to 10 days
T1/2 [Pharmacokinetic]
Assessment of the T1/2 of ONO-2910
Measured: Up to 10 days
CL/F [Pharmacokinetic]
Assessment of the CL/F of ONO-2910
Measured: Up to 10 days
fe [Pharmacokinetic]
Assessment of the Vss of ONO-2910
Measured: Up to 4 days
CLr [Pharmacokinetic]
Assessment of the CLr of ONO-2910
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start10 Jul 2020
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaharu Komeno, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504760
- Sponsor's protocol ID
- ONO-2910-01
- Status last verified
- May 2024
- First submitted
- 31 Jul 2020
- Last updated
- 3 May 2024
- Results posted
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT04504760
- Acronym / sponsor ID
- ONO-2910-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 7 Aug 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 and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.
Detailed description
This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ONO-2910 (Part A and B) | Experimental | Drug: ONO-2910 |
| Placebo (Part A) | Placebo comparator | Drug: Placebo |
| ONO-2910 (Part C and D) | Experimental | Drug: ONO-2910 |
| Placebo (Part C and D) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese healthy adult male subjects (Part A and C)
- Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
- Caucasian healthy adult male subjects (Part D)
- Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)
Key exclusion criteria (3 listed)
- Subjects currently with or with a history of 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
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 |
|---|---|---|
| ONO-2910Single ascending dose of ONO-2910 will be administered orally. | Drug | ONO-2910 (Part A and B) |
| PlaceboSingle dose of placebo will be administered orally. | Drug | Placebo (Part A) |
| ONO-2910Multiple ascending dose of ONO-2910 will be administered orally. | Drug | ONO-2910 (Part C and D) |
| PlaceboMultiple dose of placebo will be administered orally. | Drug | Placebo (Part C and D) |
Primary outcome
Adverse events [Safety and Tolerability]
Time frame: Up to 13 days
Number of participants with adverse events as assessed by CTCAE v5.0
9 secondary outcomes
Cmax [Pharmacokinetic]
Time frame: Up to 10 days
Tmax [Pharmacokinetic]
Time frame: Up to 10 days
AUC24h [Pharmacokinetic]
Time frame: Up to 10 days
AUClast [Pharmacokinetic]
Time frame: Up to 10 days
AUCinf [Pharmacokinetic]
Time frame: Up to 10 days
T1/2 [Pharmacokinetic]
Time frame: Up to 10 days
CL/F [Pharmacokinetic]
Time frame: Up to 10 days
fe [Pharmacokinetic]
Time frame: Up to 4 days
CLr [Pharmacokinetic]
Time frame: Up to 4 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 3 May 2024.
- Individual participant dataSharing planned: No
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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.
Masaharu Komeno 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 ONO-2910 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 4 inclusion and 3 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 3 May 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. 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?
Adverse events [Safety and Tolerability] (time frame: Up to 13 days). 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 3 May 2024.