* Safety and PK of PXL770 in the fed state; Version 1
Research type
Research Study
Full title
A phase I, two-part, single and optional multiple dose study to assess the safety, tolerability, and pharmacokinetics of 500 and 750 mg PXL770 in healthy subjects. 20-020
IRAS ID
294009
Contact name
Clemence Chevalier
Contact email
Sponsor organisation
Poxel SA
Eudract number
2020-005718-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The study medicine (PXL770) is an experimental treatment for non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Liver disease is often caused by people drinking too much alcohol, but NASH is not related to alcohol. A healthy liver should contain little or no fat. People with NASH have high levels of fat in their liver, which causes inflammation and scarring. Over time that can cause serious liver damage, liver failure (where the liver stops working properly), and liver cancer. We hope that the study medicine will improve fat levels in the liver of patients with NASH.\n\nThe study will have 2 parts (Parts A and B). In Part A, we’ll give healthy volunteers 2 single doses of the study medicine – a dose that has been tested before and a new higher dose. Part B is optional and won’t start until we’ve reviewed the results of Part A. In Part B, we’ll give healthy volunteers repeated doses of the new higher dose of study medicine. We aim to assess the safety, tolerability, and blood levels of the study medicine. \n\nUp to 16 healthy volunteers, aged 18–55 years, will be recruited – up to 8 in Part A and 8 in Part B.\n\nParticipants will attend a screening visit during the 3 weeks before the study and take up to 3 weeks to finish the study. Participants in Part A will have 2 study sessions – in each session they’ll stay on the ward for 4 nights and make 3 outpatient visits. In Part B, participants will have 1 study session, stay on the ward for 8 nights in a row and make 1 outpatient visit. \n\nA pharmaceutical company (Poxel SA) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
London - Riverside Research Ethics Committee
REC reference
21/FT/0020
Date of REC Opinion
8 Mar 2021
REC opinion
Further Information Favourable Opinion