This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
linerixibat will be administered per the treatment sequence
GSK Investigational Site
Cambridge, United Kingdom
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Time frame: Up to 36 hours post dose
Maximum observed plasma concentration (Cmax) of linerixibat
Time frame: Up to 36 hours post dose
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)]
Time frame: Up to 36 hours post dose
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Time frame: Up to 24 hours post dose
Time of occurrence of Cmax (Tmax) of linerixibat
Time frame: Up to 36 hours post dose
Delay in achieving Tmax (Tlag) of linerixibat
Time frame: Up to 36 hours post dose
Apparent terminal phase half-life (t1/2) of linerixibat
Time frame: Up to 36 hours post dose
Apparent clearance (CL/F) of linerixibat
Time frame: Up to 36 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of linerixibat
Time frame: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
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Time frame: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Time frame: Up to 24 hours post dose
Incidence of adverse events (AEs) and of serious adverse events (SAEs)
Time frame: Up to day 52