Neurodegenerative DiseasesPhase 1NCT04578028

A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants

A Phase 1 study testing ONO-2808 in people with Neurodegenerative Diseases, run by Ono Pharmaceutical Co., Ltd. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a first in human study to determine the safety, tolerability and pharmacokinetics of ONO-2808 in healthy adult participants. The study will be conducted in 3 parts: Part A, a single-ascending dose part with an assessment of the potential food effects in non-Japanese adult participants; Part B, a single dose… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Neurodegenerative Diseases
What is being tested?: ONO-2808
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteUnited Kingdom
Study dates: 19 Aug 2020to 7 Oct 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to provide fully informed written consent.
18-55 years (Part A \& C) or ≥65 years (Part B).
Male and female participants (Women of non-child bearing potential (WONCBP)).
Agree to use an effective method of contraception.
No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.
Body mass index (BMI) of ≥18.5 to <30 kg/m2 and a body weight of at least 50 kg for males and 45 kg for females to a maximum of 100 kg, at the time of screening.
Estimated Creatinine Clearance (CrCL, Cockcroft-Gault equation) ≥90 mL/min at Screening. In Part B only, an estimated CrCL of ≥60mL/min at Screening.

Who cannot join

Mentally or legally incapacitated or with significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
History or presence of clinically significant medical, surgical or psychiatric condition (including history of suicidal behaviour) or objection by General Practitioner (GP) to participant entering trial.
Liver chemistry values above the upper limit of normal (ULN) at Screening or admission.
Sensitivity to the study drug.
Female who is pregnant or lactating or of childbearing potential.
History or presence of alcoholism or drug/chemical/substance abuse.

Show all 24Show fewer

Evidence of poor venous access as assessed by PI.
Use of any medication which may affect ONO-2808 pharmacokinetics or pharmacodynamics
Current smoker or has smoked (including use of tobacco and/or nicotine-containing products) in the previous 3 months
Positive urine drugs of abuse, cotinine or alcohol results at Screening or admission.
Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Supine resting blood pressure less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg (Part A\& C) and less than 90/40 mmHg or greater than 160/90 mmHg (Part B).
Supine resting pulse rate lower than 40 beats per minute (bpm) or higher than 100 bpm.
Clinically significant history or presence of ECG findings at screening.
Use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days or five half-lives (whichever is longer) of first dosing and throughout the study.
Consumption or intake of compounds, food or fluids that are known to be a substrate, inducer or inhibitor of CYP450 for 28 days prior to the first dosing and throughout the study.
Donation of blood or significant blood loss within 56 days prior to the first dosing, or plasma donation within 7 days prior to the first dosing.
Participation in another clinical study within the last 3 months (or 5 half-lives of the study drug, whichever is longer) prior to the first dosing.
Objection by PI
Participants who are not willing to eat a high fat breakfast
Exclusion criteria, applicable to all participants undergoing lumbar puncture for CSF collection (Part A \& C):
History of significant back pain, significant kyphosis and or scoliosis or other spinal column deformities.
History or evidence of fundoscopy suggestive of raised intracranial pressure.
History or presence of any allergy or contraindication to the local anaesthetic required for participants undergoing lumbar puncture.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Parexel International Early Phase Clinical Unit (EPCU)
London, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Randomised, Double Blind, Placebo Controlled, Single Centre, Three-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of ONO-2808 in Healthy Subjects.

Conditions: Neurodegenerative Diseases
Being tested: ONO-2808, Placebo
Keywords: Neurodegenerative Diseases
Medical subject headings: Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ONO-2808Drug
Investigational drug
PlaceboDrug
Placebo drug

Study groups in NCT04578028
Study group	Role	What they receive
ONO-2808 Part A - Fasted	Experimental	Single ascending doses of ONO-2808 or placebo orally under fasted conditions. Additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Receives: Drug: ONO-2808
ONO-2808 Placebo Part A- Fasted	Placebo comparator	Single ascending doses of ONO-2808 or placebo orally under fasted conditions Receives: Drug: Placebo
ONO-2808 Part A - Fed	Experimental	Single ascending doses of ONO-2808 or placebo orally under fed conditions Receives: Drug: ONO-2808
ONO-2808 Placebo Part A - Fed	Placebo comparator	Single ascending doses of ONO-2808 or placebo orally under fed conditions Receives: Drug: Placebo
ONO-2808 Part B	Experimental	Single dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers . Receives: Drug: ONO-2808
ONO-2808 Placebo Part B	Placebo comparator	Single dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers Receives: Drug: Placebo
ONO-2808 Part C	Experimental	Multiple ascending doses of ONO-2808 or placebo orally Receives: Drug: ONO-2808
ONO-2808 Placebo Part C	Placebo comparator	Multiple ascending doses of ONO-2808 or placebo orally Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment emergent adverse events (TEAEs) by severity.
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possible causal relationship.
Measured: Part A and B: up to day 7; Part C: up to 17 days.
Serious adverse events (SAEs)
Number of participants with SAEs. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged hospitalization, life-threatening experience or persistent disability.
Measured: Part A and B: up to day 7; Part C: up to 17 days.
Vital signs
Summary statistics of vital signs and number of participants with clinically significant changes in vital signs including pulse/heart rate, respiratory rate, and blood pressure
Measured: Part A and B: up to day 7; Part C: up to 17 days
ECG parameters
Number of participants with ECG abnormalities
Measured: Part A and B: up to day 7; Part C: up to 17 days.
Clinical laboratory tests
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis)
Measured: Part A and B: up to day 7; Part C: up to 17 days
Physical examination
Number of participants with physical examination abnormalities
Measured: Part A and B: up to day 7; Part C: up to 17 days
Neurological examination
Number of participants with neurological examination abnormalities
Measured: Part A and B: up to day 7; Part C: up to 17 days.
Number of participants with suicidal behaviour
Treatment-emergent suicidal ideation and behaviour will be monitored by using the Columbia Suicide Severity Rating Scale (C-SSRS) and reported.
Measured: Part C: up to 17 days

Secondary outcomes (12)

Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of ONO-2808
Measured: Part A & B: Day 1 through Day 7, Part C: Day 1 and 14
Pharmacokinetics (Tmax)
Assessment of the time to reach Tmax for ONO-2808
Measured: Part A & B: Day 1 through Day 7, Part C: Day 1 and 14
Pharmacokinetics (AUClast)
Assessment of the area under the concentration-time curve of ONO-2808 to last measurable concentration
Measured: Part A & B: Day 1 through Day 7
Pharmacokinetics (AUCinf)
Assessment of the area under the concentration-time curve of ONO-2808 extrapolated to infinite time in plasma
Measured: Part A & B: Day 1 through Day 7
Pharmacokinetics (AUCtau)
Assessment of the area under the concentration-time curve of ONO-2808 during the dosing interval in plasma
Measured: Part C: Day 1 and Day 14
Pharmacokinetics (T1/2)
Assessment of the terminal elimination half-time of ONO-2808 in plasma
Measured: Part A & B: Day 1 through Day 7
Pharmacokinetics (CL/F)
Assessment of the apparent clearance of ONO-2808 from plasma
Measured: Part A & B: Day 1 through Day 7
Pharmacokinetics (Vz/F)
Assessment of the apparent volume of distribution of ONO-2808 during terminal elimination phase
Measured: Part A & B: Day 1 through Day 7
Pharmacokinetics (Aetz)
Assessment of the amount of ONO-2808 excreted in urine over the period of sample collection
Measured: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14
Pharmacokinetics (Percentage fe)
Assessment of the cumulative percentage of orally administered ONO-2808 excreted into urine
Measured: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14
Pharmacokinetics (CLR)
Assessment of the renal clearance of ONO-2808 from plasma
Measured: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14.
Distribution of ONO-2808 to the brain in Part A
Assessment of ONO-2808 brain distribution by measuring drug concentration in the cerebro spinal fluid (CSF)
Measured: Part A (in selected fasted cohorts): Day 1 and 2, Part C: Day 1 and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 20207 Oct 2021

First posted8 Oct 2020
Study start19 Aug 2020
Primary completion26 Aug 2021
Study completion7 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurodegenerative DiseasesStudies 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: Sequential
Model description: This is a single centre, three-part study conducted at a specialised Phase I centre to evaluate the safety, tolerability and pharmacokinetics of ONO-2808. This study consists of: Part A single ascending dose (including an assessment of potential food effects), Part B an assessment of age, and Part C multiple ascending dose. All parts of the study are conducted in healthy male and female (women of non-child bearing potential) participants. All parts of the study will have a 28-day screening period followed by admission to the clinical unit at least one day prior to dosing (Day -1) for baseline assessments. For all Parts of the study, a sentinel dosing approach is used to mitigate the overall safety risk with at least 1 day stagger to the rest of the cohort.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04578028
Sponsor's protocol ID: ONO-2808-01
Other IDs: 2019-004693-26, 2019
Status last verified: Dec 2021
First submitted: 1 Oct 2020
Last updated: 30 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double Blind, Placebo Controlled, Single Centre, Three-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of ONO-2808 in Healthy Subjects.
ClinicalTrials.gov ID: NCT04578028
Acronym / sponsor ID: ONO-2808-01
Conditions: Neurodegenerative Diseases
Keywords: Neurodegenerative Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 19 Aug 2020 (actual)
Primary completion: 26 Aug 2021 (actual)
Study completion: 7 Oct 2021 (actual)
First posted: 8 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8
Model description: This is a single centre, three-part study conducted at a specialised Phase I centre to evaluate the safety, tolerability and pharmacokinetics of ONO-2808. This study consists of: Part A single ascending dose (including an assessment of potential food effects), Part B an assessment of age, and Part C multiple ascending dose. All parts of the study are conducted in healthy male and female (women of non-child bearing potential) participants. All parts of the study will have a 28-day screening period followed by admission to the clinical unit at least one day prior to dosing (Day -1) for baseline assessments. For all Parts of the study, a sentinel dosing approach is used to mitigate the overall safety risk with at least 1 day stagger to the rest of the cohort.

Arm	Type	Receives
ONO-2808 Part A - Fasted	Experimental	Drug: ONO-2808Single ascending doses of ONO-2808 or placebo orally under fasted conditions. Additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
ONO-2808 Placebo Part A- Fasted	Placebo comparator	Drug: PlaceboSingle ascending doses of ONO-2808 or placebo orally under fasted conditions
ONO-2808 Part A - Fed	Experimental	Drug: ONO-2808Single ascending doses of ONO-2808 or placebo orally under fed conditions
ONO-2808 Placebo Part A - Fed	Placebo comparator	Drug: PlaceboSingle ascending doses of ONO-2808 or placebo orally under fed conditions
ONO-2808 Part B	Experimental	Drug: ONO-2808Single dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers .
ONO-2808 Placebo Part B	Placebo comparator	Drug: PlaceboSingle dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers
ONO-2808 Part C	Experimental	Drug: ONO-2808Multiple ascending doses of ONO-2808 or placebo orally
ONO-2808 Placebo Part C	Placebo comparator	Drug: PlaceboMultiple ascending doses of ONO-2808 or placebo orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Able to provide fully informed written consent.
18-55 years (Part A \& C) or ≥65 years (Part B).
Male and female participants (Women of non-child bearing potential (WONCBP)).
Agree to use an effective method of contraception.
No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.

Key exclusion criteria (24 listed)

Mentally or legally incapacitated or with significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
History or presence of clinically significant medical, surgical or psychiatric condition (including history of suicidal behaviour) or objection by General Practitioner (GP) to participant entering trial.
Liver chemistry values above the upper limit of normal (ULN) at Screening or admission.
Sensitivity to the study drug.
Female who is pregnant or lactating or of childbearing potential.

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-2808Investigational drug	Drug	ONO-2808 Part A - Fasted, ONO-2808 Part A - Fed, ONO-2808 Part B, ONO-2808 Part C
PlaceboPlacebo drug	Drug	ONO-2808 Placebo Part A - Fed, ONO-2808 Placebo Part A- Fasted, ONO-2808 Placebo Part B, ONO-2808 Placebo Part C

Primary outcome

Treatment emergent adverse events (TEAEs) by severity.
Time frame: Part A and B: up to day 7; Part C: up to 17 days.
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possible causal relationship.
Serious adverse events (SAEs)
Time frame: Part A and B: up to day 7; Part C: up to 17 days.
Number of participants with SAEs. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged hospitalization, life-threatening experience or persistent disability.
Vital signs
Time frame: Part A and B: up to day 7; Part C: up to 17 days
Summary statistics of vital signs and number of participants with clinically significant changes in vital signs including pulse/heart rate, respiratory rate, and blood pressure
ECG parameters
Time frame: Part A and B: up to day 7; Part C: up to 17 days.
Number of participants with ECG abnormalities
Clinical laboratory tests
Time frame: Part A and B: up to day 7; Part C: up to 17 days
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis)
Physical examination
Time frame: Part A and B: up to day 7; Part C: up to 17 days
Number of participants with physical examination abnormalities
Neurological examination
Time frame: Part A and B: up to day 7; Part C: up to 17 days.
Number of participants with neurological examination abnormalities
Number of participants with suicidal behaviour
Time frame: Part C: up to 17 days
Treatment-emergent suicidal ideation and behaviour will be monitored by using the Columbia Suicide Severity Rating Scale (C-SSRS) and reported.

12 secondary outcomes

Pharmacokinetics (Cmax)
Time frame: Part A & B: Day 1 through Day 7, Part C: Day 1 and 14
Pharmacokinetics (Tmax)
Time frame: Part A & B: Day 1 through Day 7, Part C: Day 1 and 14
Pharmacokinetics (AUClast)
Time frame: Part A & B: Day 1 through Day 7
Pharmacokinetics (AUCinf)
Time frame: Part A & B: Day 1 through Day 7
Pharmacokinetics (AUCtau)
Time frame: Part C: Day 1 and Day 14
Pharmacokinetics (T1/2)
Time frame: Part A & B: Day 1 through Day 7
Pharmacokinetics (CL/F)
Time frame: Part A & B: Day 1 through Day 7
Pharmacokinetics (Vz/F)
Time frame: Part A & B: Day 1 through Day 7
Pharmacokinetics (Aetz)
Time frame: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14
Pharmacokinetics (Percentage fe)
Time frame: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14
Pharmacokinetics (CLR)
Time frame: Part A & B: Day 1 through Day 5, Part C: Day 1, 8 & 14.
Distribution of ONO-2808 to the brain in Part A
Time frame: Part A (in selected fasted cohorts): Day 1 and 2, Part C: Day 1 and Day 14

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 Dec 2021.
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.

Pablo F Soto, MD,MSc, PhD principal investigator

Parexel

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-2808 in people with Neurodegenerative Diseases, run by Ono Pharmaceutical Co., Ltd. at 1 site in United Kingdom.

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 7 inclusion and 24 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 Dec 2021. 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 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?

Treatment emergent adverse events (TEAEs) by severity. (time frame: Part A and B: up to day 7; Part C: up to 17 days.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578028.

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 Dec 2021.