Bioavailability of Obeticholic Acid in Healthy Subjects (QBR116482)
Research type
Research Study
Full title
A Phase 1, Open-Label Trial of the Absorption, Metabolism, Excretion, and Absolute Bioavailability of Obeticholic Acid in Healthy Male Subjects
IRAS ID
159207
Contact name
Pui Man Leung
Contact email
Sponsor organisation
Intercept Pharmaceuticals, Inc.
Eudract number
2014-000618-79
Research summary
The study drug is called Obeticholic acid (OCA). This is being developed by Intercept Pharmaceuticals as a treatment for primary biliary cirrhosis (PBC) in patients who may not respond to other treatments. PBC is a chronic (long-lasting) liver disease.
The study will consist of two parts. The purpose of Part 1 of the study is to look at how OCA (the study drug) is absorbed by the body when given by mouth (orally) and how radiolabelled [14C]-OCA is taken up by the body when given through an intravenous injection (into a vein). The level of the drug will be determined from blood samples taken during the period of the study. Approximately 8 healthy male subjects will be administered a 25 mg OCA tablet and a 15 minute IV infusion of 100 µg [14C]-OCA.
Part 2 will investigate a radiolabelled oral dose of [14C]-OCA. The purpose of Part 2 of the study is to measure how radiolabelled OCA is absorbed, broken down and removed from the body when given orally (by mouth) by measuring the level of the study drug in blood, urine and faecal samples. Approximately 8 healthy male subjects will receive a single oral dose of a 25 mg [14C]-OCA capsule.
REC name
Wales REC 2
REC reference
14/WA/1062
Date of REC Opinion
24 Jul 2014
REC opinion
Further Information Favourable Opinion