This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist.
The First Hospital of Jilin University
Changchun, Jilin, China
Maximum concentration (Cmax)
Maximum plasma drug concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Area under the plasma concentration-time curve
The area enclosed by the blood concentration curve to the timeline
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Time to maximum concentration (Tmax)
The time required to reach peak concentration after administration
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Apparent volume of distribution (Vd/F)
Drug dose reach a dynamic balance in the body the body and blood drug concentration ratio constant
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Apparent plasma clearance (CL/F)
The volume of plasma with drug cleared per unit of time
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Plasma elimination half-life (t1/2)
The time it takes for the terminal phase blood concentration to drop by half
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Time to maximum concentration at steady state (Tmax, ss) in Part B
The time required to reach peak steady-state concentration after administration
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Maximum concentration at steady state (Cmax, ss) in Part B
The maximum blood drug concentration that occurs after stabilization
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Minimum concentration at steady state (Cmin, ss) in Part B
The minimum blood drug concentration that occurs after stabilization
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Average steady-state plasma concentration (Cav, ss) in Part B
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Adverse event rate
The occurrence rate of all adverse events (AEs), and adverse events of special interest (AESI) and serious adverse events (SAEs).
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Adverse event rate
The occurrence rate of abnormal clinical laboratory tests, vital signs, physical examination and 12 lead-electrocardiogram (ECG).
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
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