Absorption and elimination of radiolabelled linerixibat, v1
Research type
Research Study
Full title
A two-period study in healthy male participants to determine the pharmacokinetics, balance/excretion, and metabolism of [14C]-linerixibat following a single intravenous radiolabeled microtracer dose (concomitant with a non-radiolabeled oral dose) and a single oral radiolabeled dose (HMR code: 18-026)
IRAS ID
263794
Contact name
Karl Thorpe
Contact email
Sponsor organisation
GlaxoSmithKline (GSK)
Eudract number
2019-000875-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The study medicine is an experimental new medicine for treating primary biliary cholangitis (PBC), a rare autoimmune condition of the liver that causes scarring in the liver, and ultimately, liver failure. The most common symptom is intense itching, related to the build-up of bile acid (produced by the liver to help digestion) in the liver. We hope that, by inhibiting a bile acid transporter, the study medicine will prevent bile acid build-up and related itching.
The study medicine has already been tested in healthy people and patients. We’re doing this study to find out the blood levels of the study medicine, how the body gets rid of it, and how long that takes. We'll also check for side effects.
We’ll enrol 6 healthy men, aged 30–55 years. They’ll have 2 study sessions and will receive the following:
*Session 1: 1 dose of study medicine by a 3-hour slow injection into a vein, and 1 dose by mouth, as 2 tablets
*Session 2: 1 dose of study medicine by mouth, as a liquid.We’ll ‘label’ the study medicine that participants receive by slow injection and by mouth as a liquid with a small amount of radioactivity, called carbon-14, so that we can detect traces of it and any breakdown products, in blood, urine, faeces (‘poo’) and bile.
Participants will take up to 5 weeks to finish the study. There is an outpatient screening visit in the 4 weeks before starting the study. During the study, participants stay on the ward for 16 nights (8 nights in each session) and make 1 additional outpatient visit. Participants may need to stay longer during Session 2, depending on the results.
A pharmaceutical company, GSK, is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
19/NI/0076
Date of REC Opinion
9 May 2019
REC opinion
Favourable Opinion