A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants

Official title

A Single-Center, Open-Label, Multiple-Period Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants

Overview

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.

Interventions

• Drug ABSK-011 Capsules
  ABSK-011 Capsules
• Drug omeprazole enteric-coated tablets
  ABSK-011 Capsules、omeprazole enteric-coated tablets

Primary outcome measures

• Peak concentration (Cmax) [Time frame: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours]
• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) [Time frame: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours]
• Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) [Time frame: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours]
• Time to maximum plasma concentration (tmax) [Time frame: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours]

Eligibility criteria

Inclusion criteria

• 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;
• Willing to participate in this study, understand the study procedures and sign the informed consent form prior to screening; willing to comply with the study procedures.

Exclusion criteria

• 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;
• Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole, Rabeprazole, pantoprazole, etc.) within 14 days before the first dose;
• Those who have used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, star fruits, grapefruits, Seville oranges and fruit juices or other processed products) within 14 days before the first dose, or have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products;
• For those who have used CYP2C19 inhibitors or inducers (including fluoxetine, fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part B only);
• There are factors that significantly affect drug absorption, distribution, metabolism and excretion, such as inability to take oral experimental drugs (dysphagia), significant nausea, vomiting and malabsorption, history of gastric or intestinal surgery, or other surgical history that affects drug absorption, distribution, metabolism and excretion (except appendicitis surgery);
• Patients with needle fainting, blood fainting history, or inability to tolerate venipunction, or difficulty in blood collection;
• Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period);
• Have special dietary requirements, can not comply with the unified diet (such as the standard meal food intolerance, lactose intolerance, etc.) and the corresponding regulations, or have swallowing difficulties;
• Those who do not wish to comply with the dietary requirements/restrictions during the study period, which are: (i) Only consume meals provided by the study center during hospitalization; (ii) Avoid P-gp inhibitors throughout the study period;(iii) Avoid moderate and strong CYP3A4 inhibitors or inducers throughout the study period;(iv) Avoid other strong CYP2C19 inhibitors or inducers throughout the study period.
• Those who consumed more than 14 units of alcohol per week in the 3 months prior to screening (1 unit of alcohol is about 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or whose alcohol breath test results were > 0mg/100ml, or those who cannot abstain from alcohol during the study;
• Smokers who smoked more than 5 cigarettes per day (or a corresponding amount of tobacco or nicotine products) in the 3 months prior to screening; Or unable to stop using any tobacco products during the trial;
• People who had excessive methylxanthine/caffeine consumption in the past 6 months (excess consumption was defined as consuming more than 6 units of caffeine per day, with 1 unit of caffeine equivalent to 177 ml of coffee, 355 ml of tea, 355 ml of cola, or 85 grams of chocolate), Or were unwilling to comply with the methylxanthine/caffeine use restrictions in 5.3.3 during the study period, or had a known history of substance abuse or screened positive for substance abuse;
• Hepatitis B surface antigen, treponema pallidum antibody, antibody to human immunodeficiency virus, antibody to hepatitis C antibody were abnormal and were clinically significant determined by the investigator;
• Participants with a history of bacterial, fungal, parasitic, viral (excluding nasopharyngitis) or mycobacterium infection within 45 days prior to the first administration, or imaging findings (chest radiograph) supporting related infections (as determined by the investigator);
• had been vaccinated within 2 months prior to the first dose, or intended to be vaccinated throughout the study period;
• Any other factors that the investigator considers inappropriate for participation in this trial, which may affect the participant's adherence to the protocol, interfere with the interpretation of the study results, or expose the participant to risk. Or subjects withdraw from the experiment for their own reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• Affiliated Hospital of Jiangnan University — Wuxi

Identifiers

NCT: NCT07700953 · ABSK-011-104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗