FIH study exploring safety,tolerability and PK of ONO-4474 (QCL117375)
Research type
Research Study
Full title
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.
IRAS ID
174694
Contact name
Hitoshi Kajitani
Contact email
Sponsor organisation
ONO Pharmaceuticals Co. Ltd.
Eudract number
2014-004890-18
Duration of Study in the UK
0 years, 8 months, 22 days
Research summary
The Sponsor is developing the study drug, ONO-4474, as a pharmacotherapy for the management of pain associated with osteoarthritis.
The study will try to identify the safety, tolerability and how the study drug is taken up by the body.
This study is the first administration of ONO-4474 to humans and will be conducted in 4 Parts. Parts A and B will investigate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of ONO-4474, including the effect of food on ONO-4474 PK, in healthy adult volunteers in the UK. Part C will investigate the pharmacology of ONO-4474 using NGF-induced hyperalgesia in healthy volunteers in Denmark. Part D will investigate the safety and tolerability of ONO-4474 including the effect of age on PK in healthy elderly volunteers in the UK.
REC name
Wales REC 1
REC reference
15/WA/0079
Date of REC Opinion
29 Apr 2015
REC opinion
Further Information Favourable Opinion