Mass Balance, Metabolite Profile and Identification of [14C]-Rencofilstat (QSC204643)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Rencofilstat in Healthy Male Subjects
IRAS ID
1007072
Contact name
Jill Greytok
Contact email
Sponsor organisation
Hepion Pharmaceuticals, Inc
Eudract number
2022-003789-20
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, rencofilstat (previously known as CRV431), for the potential treatment of Non-alcoholic Steatohepatitis (NASH) and Hepatocellular Carcinoma (HCC). NASH is a condition in which the body stores excess fat in the liver cells, making it difficult for the liver to function properly. NASH is characterised by liver inflammation, which increases the risk of developing cirrhosis (scar tissue that prevents the liver from functioning properly) and liver cancer. HCC represents the majority of primary liver cancers.
This single-period, healthy volunteer study will examine how the test medicine is taken up, broken down and removed from the body. The breakdown products of the test medicine will also be investigated. To do this, a radiolabelled form of the test medicine will be given in liquid form (as an oral suspension). ‘Radiolabelled’ means that the test medicine has a radioactive component, Carbon-14, which allows the test medicine to be tracked.
This study will take place at one non-NHS site, enrolling up to 6 male volunteers aged between 30-65 years.
On Day 1 of the study, up to 6 volunteers in a fasted state will receive a 225 mg oral dose of the test medicine in the form of an oral emulsion (the test medicine is in an oil which will then be mixed with water and given as a drink). Volunteers will be required to stay in the clinic until at least Day 22, however this may be extended up to Day 26. After discharge, volunteers may need to attend up to two return visits between Day 28 and Day 37 if they have not reached the radioactive requirements at the time of discharge.Volunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and for safety assessments.
Volunteers are expected to be involved in this study for approximately 8 to 9 weeks from screening to the follow-up visit.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0019
Date of REC Opinion
9 Mar 2023
REC opinion
Further Information Favourable Opinion