Linerixibat and Ocaliva drug interaction study in healthy participants
Research type
Research Study
Full title
An open-label, single sequence crossover, drug interaction study to investigate the effect of linerixibat (GSK2330672) on plasma concentrations of obeticholic acid and conjugates in healthy participants
IRAS ID
268307
Contact name
Ciara Gorey
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2019-001581-15
Duration of Study in the UK
0 years, 11 months, 19 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine (linerixibat) to treat cholestatic pruritus (itch) in patients with Primary Biliary Cholangitis (PBC), a type of rare liver disease. Normally, the liver releases a liquid called bile, which helps digest fat and remove waste from the body. In PBC, the body mistakenly attacks the bile ducts, which causes bile to build up and damage the liver. If untreated, it can lead to liver failure and death.
Linerixibat reduces bile in the body, which is thought to be the cause of the itch. However, linerixibat does not treat PBC, so it is intended for use with other PBC treatments.
Ocaliva® (OCA) is approved to treat PBC when other treatments fail or cannot be tolerated. Itch is common in PBC patients and a known side effect of taking OCA.
This study is the first time linerixibat and OCA will be given together and aims to assess the effect linerixibat may have on levels of OCA in the blood, when the drugs are taken together.
This study will be conducted in healthy volunteers in two parts:
• Part A: Approximately 19 participants will be dosed OCA once daily from day 1 to 37, and twice daily doses of linerixibat from day 20 to 38. Participants will stay in the clinical unit for two days initially, home dose OCA for 15 days, and return to the unit for the final 21 days.
• Optional Part B: Number of participants and study design will remain the same as Part A. Participants will be dosed OCA and linerixibat once daily from day 1 to 37, with an intended 12-hour gap between dosing the different drugs.
The study is sponsored by GSK and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited unit in the UK.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1196
Date of REC Opinion
30 Jul 2019
REC opinion
Favourable Opinion