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

NCT07700953 | Recruiting Phase 1

• 1 other identifier: ABSK-011-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Peak concentration (Cmax)

  Peak concentration, the maximum observed plasma concentration of ABSK-011

  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-∞)

  Area under the plasma concentration-time curve from time 0 to infinity of ABSK-011

  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)

  Area under the plasma concentration-time curve from time 0 to the last measurable concentration of ABSK-011

  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 to maximum plasma concentration of ABSK-011

  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

Study Arms (4)

Sequence A

EXPERIMENTAL

Participants in Sequence A will receive 200 mg ABSK-011 Capsules orally under fasted conditions on the morning of Day 1 of Cycle 1 (C1D1), followed by 200 mg ABSK-011 Capsules after a low-fat meal on the morning of Day 1 of Cycle 2 (C2D1), and 200 mg ABSK-011 Capsules after a high-fat meal on the morning of Day 1 of Cycle 3 (C3D1).

Drug: ABSK-011 Capsules

Sequence B

EXPERIMENTAL

Participants in Sequence B will receive 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C2D1, and 200 mg ABSK-011 Capsules under fasted conditions on the morning of C3D1.

Drug: ABSK-011 Capsules

Sequence C

EXPERIMENTAL

Participants in Sequence C will receive 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules under fasted conditions on the morning of C2D1, and 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C3D1.

Drug: ABSK-011 Capsules

Omeprazole + Low-Fat Meal + ABSK-011

EXPERIMENTAL

Participants will receive 200 mg ABSK-011 Capsules following a low-fat meal on the morning of Day 1 of Cycle 1 (C1D1). During Days 1 to 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. On C2D5, a low-fat meal will be provided 1.5 hours (±1 minute) after omeprazole administration, and a single oral dose of 200 mg ABSK-011 Capsules will be administered 2 hours (±1 minute) after omeprazole intake.

Drug: ABSK-011 Capsules; Drug: omeprazole enteric-coated tablets

Interventions

ABSK-011 Capsules DRUG

ABSK-011 Capsules

Omeprazole + Low-Fat Meal + ABSK-011; Sequence A; Sequence B; Sequence C

omeprazole enteric-coated tablets DRUG

ABSK-011 Capsules、omeprazole enteric-coated tablets

Omeprazole + Low-Fat Meal + ABSK-011

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, China

RECRUITING

Study Officials

• Yiqing Zhao, Bachelor

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuqi Zeng, Doctor

CONTACT

+86-021-68910052; clinical@abbisko.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)