OPS 2071 AME study in healthy male Japanese subjects
Research type
Research Study
Full title
A Phase I, Open label Study to Assess the Absorption, Metabolism and Excretion of 14C OPS 2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
IRAS ID
177037
Contact name
Jim Bush
Contact email
Sponsor organisation
Otsuka Pharmaceutical Co., Ltd
Eudract number
2015-000811-41
Duration of Study in the UK
0 years, 0 months, 25 days
Research summary
OPS 2071, is an investigational medicinal product shown to have potent activity against various types of bacteria known to cause gut infections associated with antibiotic treatment. Use of antibiotics sometimes disrupts intestinal flora, which leads to an increase in harmful bacteria and eventually induces diarrhoea (antibiotic-associated diarrhoea [ADD]). Clostridium difficile (C difficile) is a bacterium resistant to most of the currently available antibiotics, and thus, is the major cause of ADD. This type of diarrhoea is specifically known as C difficile-associated diarrhoea (CDAD).
Thus, there is a need for the development of a new therapeutic agent for CDAD that resolves these issues.
The aim of this study is to determine the absorption, metabolism (breakdown in the body) and excretion of 14C OPS 2071 in healthy male Japanese subjects following a single oral administration.
Subjects will be screened within 28 days prior to dosing on Day -1. Each subject will reside at the CRU from approximately 13:00 on Day 1 until at least Day 8 (168 hours postdose). A 50 mg dose of OPS-2071 is within the anticipated clinical dose range and is considered to be high enough to fully characterise the single oral dose pharmacokinetics (what body does to the drug) of the parent compound.
An effective radiation dose of less than 1 mSv, associated with this study is considered a minor risk for healthy subjects.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0108
Date of REC Opinion
13 Apr 2015
REC opinion
Favourable Opinion