An open-label study to determine effect of Itraconazole, Fluconazole, Rifampin, and Rabeprazole on the PK of HMPL-689
A phase 1, open-label, 4-part, 2-period, fixed-sequence study to assess the effect of Itraconazole, a strong CYP3A inhibitor, the effect of Fluconazole, a moderate CYP3A/2C9 inhibitor, the effect of Rifampin, a strong CYP3A inducer, and the effect of Rabeprazole, a proton pump inhibitor on the pharmacokinetics (PK) of a single oral dose of HMPL-689 in study participants. The secondary objective is to evaluate the safety of a single oral dose of HMPL-689 administered with and without Itraconazole, Fluconazole, Rifampin, or Rabeprazole in study participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
59
Study participants will be administered 200 mg itraconazole by mouth twice daily after the pharmacokinetic blood draw on Day 3 and once daily on Days 4 to 10, inclusive.
Study participants will be administered 400 mg fluconazole by mouth daily on Day 3 after the pharmacokinetic blood draw, and 200 mg fluconazole by mouth daily on Days 4 to 10, inclusive.
Study participants will be administered 600 mg rifampin by mouth daily starting on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 11, inclusive.
QPS- Miami
Miami, Florida, United States
AUC0-t
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Time frame: From Day 1 to Day 11 (Day 12 for Rifampin)
AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (if data permit)
Time frame: From Day 1 to Day 11 (Day 12 for Rifampin)
Cmax
Maximum observed plasma concentration
Time frame: From Day 1 to Day 11 (Day 12 for Rifampin)
Incidence of AEs/SAEs
Any untoward medical occurrence associated with the use of study drug
Time frame: From Day 1 to Day 11 (Day 12 for Rifampin)
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Study participants will be administered 40 mg rabeprazole by mouth daily on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 9, inclusive.