PK and Safety Study with OCA in Moderate to Severe Impaired Liver PBC
Research type
Research Study
Full title
A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
IRAS ID
246539
Contact name
Michael Heneghan
Contact email
Sponsor organisation
Intercept Pharmaceuticals, Inc.
Eudract number
2017-001762-13
Duration of Study in the UK
3 years, 2 months, 14 days
Research summary
This is a Phase 4, Double-Blind, Randomized, Placebo-Controlled Study to evaluate the Pharmacokinetics (absorption, distribution of the study drug) and Safety of Obeticholic Acid in participants with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment.
The study is to find out how study drug, OCA, is absorbed and distributed through the body to determine the chemical changes of the study drug while it is in the body and identify how the study drug is excreted out of the body and is called Pharmacokinetics, or PK. The Sponsor will also be studying the safety of OCA.
The maximum amount of time that a participant could be in the study is expected to be less than 3 years. This study consists of a screening phase, involving one or two screening visits and a treatment phase of a maximum of 18 visits (3 years).
At the end of the treatment phase participants will need to make and end of study visit.
Participants will be randomised on a one to one basis to receive either study drug or placebo taken once a week initially and may increase to twice a week which is dependent on participants blood results and tolerance of study drug. Participants will need to fast prior to each visit.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0294
Date of REC Opinion
21 Mar 2019
REC opinion
Unfavourable Opinion