Assess the safety, tolerability and PK of ONO-2808 in healthy subjects
Research type
Research Study
Full title
A randomised, double blind, placebo controlled, single centre, four-part study to assess the safety, tolerability and pharmacokinetics of single and multiple oral doses of ONO-2808 in non-Japanese and Japanese healthy subjects\n
IRAS ID
276764
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Ono Pharmaceutical Co., Ltd.
Eudract number
2019-004693-26
Duration of Study in the UK
0 years, 9 months, 8 days
Research summary
Summary of Research
This is a randomised, double blind, placebo controlled, single centre, three-part study to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of ONO-2808 in healthy subjects. The study drug, ONO-2808 is being developed by Ono Pharmaceutical Co., Ltd. for oral treatment and prevention of neurodegenerative diseases. \n\nThis is a first-in-human clinical trial. The main purpose of the study is to see how safe ONO-2808 is and how well the body tolerates the study drug after single and repeated oral doses. The study will also investigate how ONO-2808 is taken up into the body, chemically broken down, distributed through the body, and excreted from the body under different conditions (overall referred to as PK), and if there are noticeable breakdown products. Drug concentrations in brain fluid, ethnicity differences and biomarkers will be investigated. An optional genetic sample will be collected.\n\nThe three study parts are: Part A single ascending dose (including assessment of food-effect), Part B an assessment of age-effect, and Part C multiple ascending doses. All study parts are to be conducted in healthy males and females of non-childbearing potential. Each study part will include a screening visit, a treatment period and a follow-up visit. Eligible participants will remain residential at the Clinical Unit for the full duration of the treatment period. Sentinel dosing applies to all cohorts in all study parts. Approximately 112 subjects may participate in the study.
Summary of Results
Not provided for reasons of commercial sensitivity. ONO-2808-01 is a Phase 1 study.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0017
Date of REC Opinion
10 Feb 2020
REC opinion
Favourable Opinion