Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Status:
Completed
Trial end date:
2019-08-26
Target enrollment:
Participant gender:
Summary
Absorption, metabolism and excretion of linerixibat have been studied in previous clinical
trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion
have been conducted for linerixibat. The purpose of this study is to determine the PK,
balance/excretion, and metabolism of radiolabeled 14 Carbon [14C]-linerixibat following a
single intravenous (IV) radiolabeled microtracer dose (concomitant with a non-radiolabeled
oral dose) and a single oral radiolabeled dose. This is a single group, two period, single
sequence, and mass balance study will enroll 6 healthy male subjects. Each subject will be
involved in the study for up to 10 weeks which includes screening period, two treatment
periods (treatment Periods 1 and 2), separated by about 7 days (at least 13 days between oral
doses), and a follow-up visit 1-2 weeks after the last assessment in treatment Period 2.