Food effect study of linerixibat tablets in healthy adult participants
Research type
Research Study
Full title
A Phase1, randomized, open-label, single dose, 2 period crossover study to evaluate the effect of food on the pharmacokinetics of linerixibat tablets in healthy adult participants.
IRAS ID
1005566
Contact name
Abby Mitchell
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2022-000884-27
Clinicaltrials.gov Identifier
Research summary
Research Summary
This study will test the effect of food on a new drug (linerixibat), which has not yet been approved by the national health agency in the UK. This drug is only given to people who participate in clinical trials.
The drug tested in this study is being developed by GSK for the treatment of itchy skin frequently experienced by patients with a chronic liver disease called primary biliary cholangitis (PBC).
In healthy individuals the liver produces a liquid called bile that is released into the gut to help digest and absorb fats along with certain vitamins. The majority of bile is then reabsorbed from the gut into the blood circulation and returns to the liver.
In PBC, the immune system mistakenly attacks and damages the tunnels within the liver that carry bile to the gut meaning bile cannot leave the liver properly. As a result, bile builds up in the blood circulation and the build-up of bile in the body is thought to be the cause of the itch.
Linerixibat works in the gut by blocking bile from reentering the blood, stops it from building up, as it causes the bile to be removed in stools instead.
So far, linerixibat has been given to 284 participants in completed clinical trials. Linerixibat was tested in healthy volunteers as well as patients with itch associated to PBC. Most of the 284 participants were 18 to 64 years of age and more than half were female.This study is being done to test if the safety and effectiveness of linerixibat is affected when taken with or without food.
Approximately 14 healthy male and female adults who are between 18 and 55 years of age will be enrolled in this study. You have been invited to participate because you meet these two criteria.
The study will last for approximately 8 weeks for each participant.Summary of Results
It has been decided that these study results are not medically or scientifically significant. The reason for this is that Linerixibat is not available outside clinical studies and the dosing posology in these studies will not be changed as a consequence of this data. We also want to ensure that when we publish this data, our interpretation of the results is consistent with the labelling of the product which means that we need to wait until approval for this to be ensured.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0100
Date of REC Opinion
13 Jun 2022
REC opinion
Further Information Favourable Opinion