Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
Status:
Completed
Trial end date:
2019-11-25
Target enrollment:
Participant gender:
Summary
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking
obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC],
OCA, or both) the addition of linerixibat to OCA therapy may be considered following
marketing approval. It is therefore important to characterize any potential effect of
linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages.
Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and
OCA (potential victim) will be conducted to inform both future clinical trials with
linerixibat and the potential concomitant administration of these drugs in a clinical
setting. This is a single-center, one part (with optional second part) open-label, single
sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma
concentrations of OCA and OCA conjugates in healthy participants. Approximately 19
participants will be enrolled in part A and further 19 participants in part B (if performed)
in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.