This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
OCA will be administered
Linerixibat will be administered
GSK Investigational Site
Baltimore, Maryland, United States
Average trough concentration (Ctrough) in plasma for total-OCA at steady state
Time frame: Days 35 to 38
Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: At Day 18 and Day 37
AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: Up to 24 hours on Day 18 and Day 37
Maximum observed plasma concentration (Cmax) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: At Day 18 and Day 37
Average trough concentration (Ctrough) in plasma for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: Days 17 to 19 and Days 35 to 38
Time to maximum concentration (Tmax) for OCA, tauro-OCA, glyco-OCA and total-OCA
Time frame: At Day 18 and Day 37
Ctrough of total OCA over Days 17 to 19 and Days 35 to 38
Time frame: Days 17 to 19 and Days 35 to 38
Number of participants with adverse events
Time frame: Up to Day 52
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