Absolute BA and ADME study of [14C]-Aramchol (QSC117795)
Research type
Research Study
Full title
An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability of Aramchol and to Determine the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Aramchol Administered via the Oral Route to Healthy Male Subjects
IRAS ID
273082
Contact name
Bella Shusterman
Contact email
Sponsor organisation
Galmed Research & Development Ltd.
Eudract number
2019-004816-74
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
The Sponsor is developing the test medicine, Aramchol, for the potential treatment of non-alcoholic steatohepatitis (NASH). NASH is a progressive form of non-alcoholic fatty liver disease and is recognised as a major cause of chronic liver disease.
The study aims to identify the proportion of an oral dose of the test medicine that is absorbed and reaches the blood stream and how it is processed by the body and excreted. This involves radiolabeling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. It will also look at the rate and route of elimination of [14C]-Aramchol and the profiling and identification of any metabolites (breakdown products of the test medicine).
Blood, urine and faecal samples will be collected from volunteers throughout the study, allowing identification and profiling of metabolites from Aramchol to learn the structure and properties of these. The amount of Aramchol and radioactivity found in each sample will also be assessed.
Approximately 6 healthy male volunteers will be enrolled in this study. Each volunteer will receive three doses of the test medicine. Two doses will be administered in Part 1, where volunteers will receive a 300 mg tablet of the test medicine, followed by a radiolabelled intravenous dose of the test medicine 11.75 hours after the tablet dose. Blood, urine and faecal samples will be taken at regular intervals for approximately 8 days in Part 1.
Following Part 1, there will be a minimum washout period of 21 days. In Part 2, the same volunteers will receive a radiolabelled oral suspension of the test medicine. More blood, urine and faecal samples will be taken for approximately 8 days in Part 2. Volunteers will receive a follow-up phone call 7 to 10 days after discharge to ensure their continued wellbeing.
Research Summary
Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.Summary of Results
Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0573
Date of REC Opinion
14 Apr 2020
REC opinion
Favourable Opinion