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

NCT ID: NCT04578028

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2021-10-07

Brief Summary

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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 part to assess the effect of age in non-Japanese elderly participants; and Part C, a multiple-ascending dose part with ONO-2808 administered to healthy subjects.

Detailed Description

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Conditions

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Neurodegenerative Diseases

Keywords

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Neurodegenerative Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
This is a double-blind study. A sentinel dosing approach will be used in the study at each new ascending dose level in Part A, B, and C. To maintain the blinded nature of the study, the sentinel participants will be randomised to drug or placebo in a 1:1 ratio.

Study Groups

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ONO-2808 Part A - Fasted

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.

Group Type EXPERIMENTAL

ONO-2808

Intervention Type DRUG

Investigational drug

ONO-2808 Placebo Part A- Fasted

Single ascending doses of ONO-2808 or placebo orally under fasted conditions

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drug

ONO-2808 Part A - Fed

Single ascending doses of ONO-2808 or placebo orally under fed conditions

Group Type EXPERIMENTAL

ONO-2808

Intervention Type DRUG

Investigational drug

ONO-2808 Placebo Part A - Fed

Single ascending doses of ONO-2808 or placebo orally under fed conditions

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drug

ONO-2808 Part B

Single dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers .

Group Type EXPERIMENTAL

ONO-2808

Intervention Type DRUG

Investigational drug

ONO-2808 Placebo Part B

Single dose of ONO-2808 or placebo in elderly female or elderly male healthy volunteers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drug

ONO-2808 Part C

Multiple ascending doses of ONO-2808 or placebo orally

Group Type EXPERIMENTAL

ONO-2808

Intervention Type DRUG

Investigational drug

ONO-2808 Placebo Part C

Multiple ascending doses of ONO-2808 or placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drug

Interventions

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ONO-2808

Investigational drug

Intervention Type DRUG

Placebo

Placebo drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able to provide fully informed written consent.
2. 18-55 years (Part A \& C) or ≥65 years (Part B).
3. Male and female participants (Women of non-child bearing potential (WONCBP)).
4. Agree to use an effective method of contraception.
5. No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.
6. 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.
7. Estimated Creatinine Clearance (CrCL, Cockcroft-Gault equation) ≥90 mL/min at Screening. In Part B only, an estimated CrCL of ≥60mL/min at Screening.

Exclusion Criteria

1. Mentally or legally incapacitated or with significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
2. 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.
3. Liver chemistry values above the upper limit of normal (ULN) at Screening or admission.
4. Sensitivity to the study drug.
5. Female who is pregnant or lactating or of childbearing potential.
6. History or presence of alcoholism or drug/chemical/substance abuse.
7. Evidence of poor venous access as assessed by PI.
8. Use of any medication which may affect ONO-2808 pharmacokinetics or pharmacodynamics
9. Current smoker or has smoked (including use of tobacco and/or nicotine-containing products) in the previous 3 months
10. Positive urine drugs of abuse, cotinine or alcohol results at Screening or admission.
11. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
12. 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).
13. Supine resting pulse rate lower than 40 beats per minute (bpm) or higher than 100 bpm.
14. Clinically significant history or presence of ECG findings at screening.
15. 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.
16. 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.
17. 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.
18. 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.
19. Objection by PI
20. Participants who are not willing to eat a high fat breakfast

21. History of significant back pain, significant kyphosis and or scoliosis or other spinal column deformities.
22. History or evidence of fundoscopy suggestive of raised intracranial pressure.
23. History or presence of any allergy or contraindication to the local anaesthetic required for participants undergoing lumbar puncture.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo F Soto, MD,MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Parexel International Early Phase Clinical Unit (EPCU)

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2019-004693-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ONO-2808-01

Identifier Type: -

Identifier Source: org_study_id