This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
High Point Clinical Trials Center
High Point, North Carolina, United States
PK parameters of PXL770
AUC : Area under the plasma concentration curve
Time frame: Day 26
Plasma PK parameters of PXL770
Minimum plasma concentration (Cmin)
Time frame: Day 26
Plasma PK parameters of PXL770
Average plasma concentration (Cavg)
Time frame: Day 26
Plasma PK parameters of PXL770
Time to maximum plasma concentration (Tmax)
Time frame: Day 26
Plasma PK parameters of PXL770
Apparent volume of distribution (Vz/F)
Time frame: Day 26
Plasma PK parameters of PXL770
Apparent oral drug clearance at steady state (CLss/F)
Time frame: Day 26
Plasma PK parameters of PXL770
Elimination rate constant (λz)
Time frame: Day 26
Plasma PK parameters of PXL770
Terminal elimination half-life (t½)
Time frame: Day 26
Plasma PK parameters of PXL770
Area under the concentration-time curve from time 0 to last observed concentration (AUClast)
Time frame: Day 26
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Plasma PK parameters of PXL770
Food effect: Cmax
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
Food effect: AUCtau
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
Food effect: Tmax
Time frame: Day 14 and Day 26
Plasma PK parameters of PXL770
PK profile during OGTT: AUCtau
Time frame: Day 27
Plasma PK parameters of PXL770
PK profile during OGTT: Cmax
Time frame: Day 27