The purpose of this study is to evaluate the pharmacokinetics and safety of ASP015K after single-dose and multiple-dose administration in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Oral
Site CN86001
Beijing, China
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study drug or who has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug. An AE is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Time frame: Up to Day 20
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 20
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 20
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-ECG values.
Time frame: Up to Day 20
Number of participants with physical examination abnormalities and/or AEs
Number of participants with potentially clinically significant physical examination observations.
Time frame: Up to Day 20
Pharmacokinetics (PK) of peficitinib: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK serum samples collected.
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Time frame: On Day 1
PK of peficitinib: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 8
PK of peficitinib: AUC from the time of dosing to 24 hours post dose (AUC24h)
AUC24h will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib: Apparent total systemic clearance after extravascular dosing (CL/F)
CL/F will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 13
PK of peficitinib: Maximum concertation (Cmax)
Cmax will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib: Terminal elimination rate constant (Lambdaz)
Lambdaz will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 13
PK of peficitinib: Terminal elimination half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 13
PK of peficitinib: Time of the maximum concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib: Apparent volume of distribution during the terminal elimination phase after single extravascular dosing (VzF)
VzF will be recorded from the PK serum samples collected.
Time frame: On Day 1
PK of peficitinib: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK serum samples collected.
Time frame: On Day 9 to 12 and 13
PK of peficitinib: Concentration at 24 hours post dosing (C24h)
C24h will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib: Peak trough ratio (PTR)
PTR will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib: Accumulation ratio calculated using AUC (Rac(AUC24h))
Rac(AUC) will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib: Accumulation ratio calculated using the maximum concentration (Rac (Cmax))
Rac(Cmax)will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib metabolite: AUCinf
AUCinf will be recorded from the PK serum samples collected.
Time frame: On Day 1
PK of peficitinib metabolite: AUClast
AUClast will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 8
PK of peficitinib metabolite: AUC24h
AUC24h will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib metabolite: Cmax
Cmax will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib metabolite: Lambdaz
Lambdaz will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 13
PK of peficitinib metabolite: t1/2
t1/2 will be recorded from the PK serum samples collected.
Time frame: On Day 1 and 13
PK of peficitinib metabolite: tmax
tmax will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13
PK of peficitinib metabolite: Ctrough
Ctrough will be recorded from the PK serum samples collected.
Time frame: On Day 9 to 12 and 13
PK of peficitinib metabolite: C24h
C24h will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib metabolite: PTR
PTR will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib metabolite: Rac(AUC24h)
Rac(AUC24h) will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib metabolite: Rac(Cmax)
Rac(Cmax) will be recorded from the PK serum samples collected.
Time frame: On Day 13
PK of peficitinib metabolite: Metabolite to parent ratio of the area under the concentration-time curve corrected by the molecular weight ratio of parent to metabolite (MPR)
MPR will be recorded from the PK serum samples collected.
Time frame: On Day 1, 8 and 13