Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
peficitinib · 1 trial · 1 indication
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.
Number of participants with potentially clinically significant laboratory values.
Number of participants with potentially clinically significant vital sign values.
Number of participants with potentially clinically significant 12-ECG values.
Number of participants with potentially clinically significant physical examination observations.
AUCinf will be recorded from the PK serum samples collected.
AUClast will be recorded from the PK serum samples collected.
AUC24h will be recorded from the PK serum samples collected.
CL/F will be recorded from the PK serum samples collected.
Cmax will be recorded from the PK serum samples collected.
Lambdaz will be recorded from the PK serum samples collected.
t1/2 will be recorded from the PK serum samples collected.
tmax will be recorded from the PK serum samples collected.
VzF will be recorded from the PK serum samples collected.
Ctrough will be recorded from the PK serum samples collected.
C24h will be recorded from the PK serum samples collected.
PTR will be recorded from the PK serum samples collected.
Rac(AUC) will be recorded from the PK serum samples collected.
Rac(Cmax)will be recorded from the PK serum samples collected.
AUCinf will be recorded from the PK serum samples collected.
AUClast will be recorded from the PK serum samples collected.
AUC24h will be recorded from the PK serum samples collected.
Cmax will be recorded from the PK serum samples collected.
Lambdaz will be recorded from the PK serum samples collected.
t1/2 will be recorded from the PK serum samples collected.
tmax will be recorded from the PK serum samples collected.
Ctrough will be recorded from the PK serum samples collected.
C24h will be recorded from the PK serum samples collected.
PTR will be recorded from the PK serum samples collected.
Rac(AUC24h) will be recorded from the PK serum samples collected.
Rac(Cmax) will be recorded from the PK serum samples collected.
MPR will be recorded from the PK serum samples collected.
| Arm | Type | Description |
|---|---|---|
| Peficitinib 50 mg | EXPERIMENTAL | Participants will receive a single dose of 50 milligrams (mg) under fasted condition Day 1, followed by multiple doses of 50 mg under fed condition once daily in the morning from Day 8 till Day 13. |
| Peficitinib 100 mg | EXPERIMENTAL | Participants will receive a single dose of 100 mg under fasted condition Day 1, followed by multiple doses of 100 mg under fed condition once daily in the morning from Day 8 till Day 13. |
| Peficitinib 150 mg | EXPERIMENTAL | Participants will receive a single dose of 150 mg under fasted condition Day 1, followed by multiple doses of 150 mg under fed condition once daily in the morning from Day 8 till Day 13. |
| Name | Type | Description |
|---|---|---|
| peficitinib | DRUG | Oral |
Inclusion Criteria: * Normal Body Mass index (BMI) and weight: BMI\[= weight kg/(height m)\^2\] \> 19 kg/m\^2 and ≤ 24 kg/m\^2, the weight is no less than 50 kg for male and 45 kg for female at screening. * Female subject must either: Be of non-childbearing potential, postmenopausal (defined as at ...