Phase 1 ADME of PXL770 in healthy male volunteers (QSC117857)
Research type
Research Study
Full title
Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
IRAS ID
252041
Contact name
Nand Singh
Contact email
Sponsor organisation
Poxel S.A.
Eudract number
2018-004275-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
The Sponsor is developing the test medicine, PXL770, for the potential treatment of non-alcoholic steato-hepatitis (NASH).
NASH is a type of non-alcoholic fatty liver disease (NAFLD), which is a condition where fat builds up in the liver. Patients with NASH have inflammation and liver cell damage, along with fat in the liver. NASH can also increase the risk of developing other conditions, including type 2 diabetes, cirrhosis (permanent liver damage) and cardiovascular (heart and circulation) disease.
The study will try to identify how the test medicine, PXL770, is absorbed (taken up), distributed, metabolised (broken down) and eliminated (removed) from the body when given orally (by mouth) as a solution.
This is a single centre, open-label, non-randomized, single-period mass balance recovery study involving up to 8 healthy male volunteers. The volunteers will receive a single dose of 250 mg radiolabelled PXL770 (14C-PXL770) containing not more than 4.5 MBq of radioactivity. ‘Radiolabelled’ means that the study drug has a radioactive component which enables researchers to track where the test medicine is in the body.
Volunteers will attend the clinical unit for 8 days (Day -1 to Day 7). It is planned that the volunteers will be discharged individually once the discharge criteria have been met. This may result in individual volunteers being discharged prior to completion of the planned residency period. If the criteria are not met by the individual volunteer by Day 7, the residency period may be extended by up to a maximum of 4 additional 24 h periods (up to Day 11) for further collection of urine and faeces.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/2129
Date of REC Opinion
10 Jan 2019
REC opinion
Further Information Favourable Opinion