A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
This study will be a single-center, open-label, 4-period, randomized,6-sequence study conducted with 24 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods1, 2, 3,and 4), and an End of Study (EOS) Phase. Screening must occur within 28 days before the first study drug administration. There will be a washout of at least 7days between 4 administrations of HMPL-523.Subjects in Periods 1, 2, and 3 will be randomized into 1 of 6 treatment sequences, with all subjects then receiving the same treatment in Period 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
700 mg HMPL-523 will be administered by mouth once daily on Day 1, Day 8, Day 15, and Day 26
40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26
PPD Austin
Austin, Texas, United States
PK parameter for HMPL-523: AUC0-t
Area under the concentration time curve from time 0 to the last measurable concentration
Time frame: Day 1 to Day 31
PK parameter for HMPL-523: AUC0-inf
Area under the concentration time curve from time 0 extrapolated to infinity
Time frame: Day 1 to Day 31
PK parameter for HMPL-523: Cmax
Maximum observed plasma concentration
Time frame: Day 1 to Day 31
PK parameter for HMPL-523: tmax
Time to reach the maximum observed plasma concentration
Time frame: Day 1 to Day 31
Assessment of safety procedures findings
Any untoward medical occurrence associated with the study drug
Time frame: Day 1 to Day 31
PK parameter for metabolite M1: AUC0-t
Area under the concentration time curve from time 0 to the last measurable concentration
Time frame: Day 1 to Day 31
PK parameter for metabolite M1: AUC0-inf
Area under the concentration time curve from time 0 extrapolated to infinity
Time frame: Day 1 to Day 31
PK parameter for metabolite M1: Cmax
Maximum observed plasma concentration
Time frame: Day 1 to Day 31
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