Phase-1 Trial to Test Formulations of OPC-224333 & Study Effect of Food and Mini Tablet Sprinkling
Research type
Research Study
Full title
A Phase 1, Open-label, Randomized Crossover Trial to Assess the Relative Bioavailability of Sustained-release Mini Tablet Formulations of OPC-224333 Compared to Immediate-release Tablets, and to Assess the Effects of Food and Intact Mini Tablet Sprinkling on the Relative Bioavailability of Sustained-release Mini Tablet Formulations in Healthy Adults
IRAS ID
1009846
Contact name
Boris Reznichenko
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc
ISRCTN Number
ISRCTN12823680
Research summary
•This is a study in healthy volunteers to understand how different formulations of a new study drug are taken up and processed by the body.
•The new study drug is being developed for the treatment of epilepsy.
•The reason for this study is to find out treatment potential and safety of OPC-224333 and to answer the following questions:
1.How do blood levels of the study drug compare when it is given in different formulations
2.Does food affect how the body absorbs the study drug (Parts 2 and 3 only)
•In addition, the study will provide more information on the safety and tolerability of the study drug and any side effects that occur
•There are up to three Parts to this study, Part 1, Part 2 (conditional) and Part 3 (conditional).
•Participants will be asked to take the study drug on up to 4 occasions, whilst in the clinical unit. This will require up to 2 visits to the study unit, including screening.
•Participant may be eligible to take part in this study if participant are a healthy male / female of non-childbearing potential and between the ages of 18 to 55 years.
•The study will be conducted at a clinical unit in Nottingham, UK.
•The study will last approximately 5 weeksREC name
Wales REC 2
REC reference
24/WA/0169
Date of REC Opinion
3 Sep 2024
REC opinion
Further Information Favourable Opinion