This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011 Capsules. A total of 15 healthy participants are planned to be enrolled. Participants will be randomized to Sequence A, Sequence B or Sequence C at a 1:1:1 ratio and receive a single oral dose of ABSK-011 (50 mg × 4) on three separate occasions with a 4-day washout interval between administrations. 39 PK blood sampling time points will be collected in Part A.
Part B is a single-center, open-label, fixed-sequence study designed to assess the impact of multiple oral doses of omeprazole enteric-coated tablets on the pharmacokinetic profiles of ABSK-011 Capsules. 15 healthy participants are planned for enrollment. On Day 1 of Cycle 1 (C1D1), participants will receive 200 mg ABSK-011 Capsules in the morning after a low-fat meal. From Day 1 to Day 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. 26 PK blood sampling time points will be collected in Part B.
Healthy subjects aged 18 to 45 years (inclusive) at screening;
Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as assessed by the investigator at Screening;
Male or female subjects of childbearing potential must agree to use effective methods of contraception during the study and within 6 months after the last dose of investigational product;
Patients with medical history or existing diseases of motor system, neuropsychiatric system, endocrine system, blood circulatory system, respiratory system, digestive system, urinary system, reproductive system, and other abnormalities, and those determined by the investigator to be clinically significant ;
Known allergic history to food, environment, experimental drug ABSK-011 or other drugs;
Participants who have participated in other clinical trials and used other clinical trial drugs or test devices within 3 months before or during the screening period, or plan to participate in other clinical trials during the study period, or participants who do not participate in clinical trials themselves;
have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011;
Crossover
ABSK-011 Capsules
DrugABSK-011 Capsules
omeprazole enteric-coated tablets
DrugABSK-011 Capsules、omeprazole enteric-coated tablets
Peak concentration (Cmax)
Peak concentration, the maximum observed plasma concentration of ABSK-011
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Area under the plasma concentration-time curve from time 0 to infinity of ABSK-011
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast)
Area under the plasma concentration-time curve from time 0 to the last measurable concentration of ABSK-011
Time to maximum plasma concentration (tmax)
Time to maximum plasma concentration of ABSK-011
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