This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
20 mg of rabeprazole will be administered orally once daily in the morning from Day 15 to Day 21, and a 300 mg oral dose of HMPL-760 will be administered concomitantly with rabeprazole on Day21.
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
AUC 0-last
Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
Time frame: Day 1 to Day 25
AUC 0-inf
Area under the plasma concentration-time curve from time 0 to infinity
Time frame: Day 1 to Day 25
Cmax
Maximum plasma concentration
Time frame: Day 1 to Day 25
Tmax
Time to Cmax
Time frame: Day 1 to Day 25
tlag
Lag Time
Time frame: Day 1 to Day 25
t1/2
Terminal elimination half-life
Time frame: Day 1 to Day 25
Adverse events rate
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: Day 1 to Day 32(±1 day)
Laboratory tests
Number of participants with abnormal laboratory tests results
Time frame: Day 1 to Day 32(±1 day)
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