OsteoarthritisPhase 1NCT02454387
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers
A Phase 1 study testing ONO-4474 Part A1, ONO-4474 Part A2 and ONO-4474 Part B in people with Osteoarthritis, run by Ono Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial summary
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ONO-4474 Part A1, ONO-4474 Part A2 and ONO-4474 Part B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Apr 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
- Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
Who cannot join
- Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
- Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Double-blind, Single and Multiple Ascending Dose, Randomised, Placebo-controlled Study, in Healthy Adult and Elderly Subjects Exploring Safety, Tolerability, Pharmacokinetics of ONO-4474 and Pharmacology of ONO-4474 in NGF-hyperalgesia
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.
Read the detailed description
A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.
- Conditions
- Osteoarthritis
- Being tested
- ONO-4474 Part A1, Placebo Part A1, ONO-4474 Part A2, Placebo Part A2, ONO-4474 Part B
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4474 Part A1Drug
Also called ONO-4474
Healthy volunteers
Placebo Part A1Drug
Also called Placebo
Healthy volunteers
ONO-4474 Part A2Drug
Also called ONO-4474
Healthy volunteers
Placebo Part A2Drug
Also called Placebo
Healthy volunteers
ONO-4474 Part BDrug
Also called ONO-4474
Healthy volunteers
Placebo Part BDrug
Also called Placebo
Healthy volunteers
ONO-4474 Part CDrug
Also called ONO-4474
Healthy volunteers
Placebo Part CDrug
Also called Placebo
Healthy volunteers
ONO-4474 Part DDrug
Also called ONO-4474
Healthy volunteers
Placebo Part DDrug
Also called Placebo
Healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ONO-4474 Part A1 | Experimental | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: ONO-4474 Part A1 |
| Experimental: ONO-4474 Placebo Part A1 | Placebo comparator | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: Placebo Part A1 |
| Experimental: ONO-4474 Part A2 | Experimental | Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: ONO-4474 Part A2 |
| Experimental: ONO-4474 Placebo Part A2 | Placebo comparator | Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: Placebo Part A2 |
| Experimental: ONO-4474 Part B | Experimental | Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: ONO-4474 Part B |
| Experimental: ONO-4474 Placebo Part B | Placebo comparator | Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: Placebo Part B |
| Experimental: ONO-4474 Part C | Experimental | NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design Receives: Drug: ONO-4474 Part C |
| Experimental: ONO-4474 Placebo Part C | Placebo comparator | NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design Receives: Drug: Placebo Part C |
| Experimental: ONO-4474 Part D | Experimental | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: ONO-4474 Part D |
| Experimental: ONO-4474 Placebo Part D | Placebo comparator | Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Receives: Drug: Placebo Part D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
Measured: Up to Day 28
Secondary outcomes (6)
Maximum plasma concentration of ONO-4474 (Cmax)
Measured: Day 1 and at Day 7
ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)
Measured: Day 1 and at Day 7
Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474
Measured: Day 1 and at Day 7
Plasma Decay half life (T1/2) of ONO-4474
Measured: Day 1 and at Day 7
Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale
Measured: 3hr and 24hr after NGF injection
Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.
Pressure algometry at site of NGF injection (anterior tibialis)
Measured: 3hr and 24hr after NGF injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Drug Development Division, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454387
- Sponsor's protocol ID
- ONO-4474-01
- Status last verified
- Jan 2016
- First submitted
- 29 Apr 2015
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Single and Multiple Ascending Dose, Randomised, Placebo-controlled Study, in Healthy Adult and Elderly Subjects Exploring Safety, Tolerability, Pharmacokinetics of ONO-4474 and Pharmacology of ONO-4474 in NGF-hyperalgesia
- ClinicalTrials.gov ID
- NCT02454387
- Acronym / sponsor ID
- ONO-4474-01
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 May 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.
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.
Detailed description
A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Experimental: ONO-4474 Part A1 | Experimental | Drug: ONO-4474 Part A1Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Placebo Part A1 | Placebo comparator | Drug: Placebo Part A1Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Part A2 | Experimental | Drug: ONO-4474 Part A2Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Placebo Part A2 | Placebo comparator | Drug: Placebo Part A2Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Part B | Experimental | Drug: ONO-4474 Part BMultiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Placebo Part B | Placebo comparator | Drug: Placebo Part BMultiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Part C | Experimental | Drug: ONO-4474 Part CNGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design |
| Experimental: ONO-4474 Placebo Part C | Placebo comparator | Drug: Placebo Part CNGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design |
| Experimental: ONO-4474 Part D | Experimental | Drug: ONO-4474 Part DSingle doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
| Experimental: ONO-4474 Placebo Part D | Placebo comparator | Drug: Placebo Part DSingle doses of ONO-4474 or placebo, randomized 3 active: 1 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
- Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
Key exclusion criteria (2 listed)
- Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
- Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
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-4474 Part A1Also: ONO-4474Healthy volunteers | Drug | Experimental: ONO-4474 Part A1 |
| Placebo Part A1Also: PlaceboHealthy volunteers | Drug | Experimental: ONO-4474 Placebo Part A1 |
| ONO-4474 Part A2Also: ONO-4474Healthy volunteers | Drug | Experimental: ONO-4474 Part A2 |
| Placebo Part A2Also: PlaceboHealthy volunteers | Drug | Experimental: ONO-4474 Placebo Part A2 |
| ONO-4474 Part BAlso: ONO-4474Healthy volunteers | Drug | Experimental: ONO-4474 Part B |
| Placebo Part BAlso: PlaceboHealthy volunteers | Drug | Experimental: ONO-4474 Placebo Part B |
| ONO-4474 Part CAlso: ONO-4474Healthy volunteers | Drug | Experimental: ONO-4474 Part C |
| Placebo Part CAlso: PlaceboHealthy volunteers | Drug | Experimental: ONO-4474 Placebo Part C |
| ONO-4474 Part DAlso: ONO-4474Healthy volunteers | Drug | Experimental: ONO-4474 Part D |
| Placebo Part DAlso: PlaceboHealthy volunteers | Drug | Experimental: ONO-4474 Placebo Part D |
Primary outcome
Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
Time frame: Up to Day 28
6 secondary outcomes
Maximum plasma concentration of ONO-4474 (Cmax)
Time frame: Day 1 and at Day 7
ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)
Time frame: Day 1 and at Day 7
Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474
Time frame: Day 1 and at Day 7
Plasma Decay half life (T1/2) of ONO-4474
Time frame: Day 1 and at Day 7
Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale
Time frame: 3hr and 24hr after NGF injection
Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.
Time frame: 3hr and 24hr after NGF injection
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 30 Jun 2016.
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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.
Drug Development Division study director
Ono Pharmaceutical Co., Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4474 Part A1, ONO-4474 Part A2 and ONO-4474 Part B in people with Osteoarthritis, run by Ono Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
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 2 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, United Kingdom. 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?
Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events (time frame: Up to Day 28). 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 30 Jun 2016.