Redx Pharma Metabolic Stability NRES application v2021
Research type
Research Study
Full title
Metabolic Stability of Drug Candidates in the Presence of Human Hepatocytes
IRAS ID
301371
Contact name
Clifford Jones
Contact email
Sponsor organisation
Redx Pharma
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Redx Pharma Plc, is a pharmaceutical company based in Cheshire, England, developing new drug candidates to treat diseases associated with fibrosis and oncology. Redx Pharma aims to discover novel compounds to develop clinically into targeted treatments in these therapeutic areas.
Measuring how quickly potential drugs are broken down/destroyed by enzymes which enable the compound to be readily excreted from the body is a key parameter for drug discovery. A metabolic stability study determines the in vitro intrinsic clearance (CLint) of a compound. The CLint value is a measure of how rapidly a compound is converted to metabolites by enzymes present in hepatocytes and is independent of other physiological factors such as blood flow. Determination of CLint within drug discovery helps to identify metabolic liabilities within a compound series, and ultimately assists in the identification of compounds with improved metabolic stability. The human in vitro CLint is then used to predict human pharmacokinetic parameters for potential clinical drug candidates. The liver is the primary organ involved in drug metabolism and as primary cells such as hepatocytes possess the full range of metabolising enzymes they are the preferred method to assess metabolic stability.REC name
Wales REC 4
REC reference
21/WA/0281
Date of REC Opinion
10 Aug 2021
REC opinion
Favourable Opinion