Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 45

How ABSK-011 behaves in the body with different meals and with an acid reducer in healthy people

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

Run by Abbisko Therapeutics Co, Ltd · NCT07700953 · Data updated 2026-11-12

This study tests how meal fat content and omeprazole affect how ABSK-011 capsules move through the body in healthy adults.

More Healthy Adult Participants trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment30 (estimated)
SponsorAbbisko Therapeutics Co, Ltd
Industry-sponsored
Locations1 site (Wuxi)
StatusRecruiting
StartedJuly 21, 2026
Main results expectedAugust 10, 2026
Study endsAugust 10, 2026
Registry record updatedJuly 27, 2026
Trial IDNCT07700953 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 18–45 who are willing to use contraception and provide informed consent.

Probably not a fit

Participants with significant medical conditions or contraindications to ABSK-011 or omeprazole may not benefit from this study's findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Part A is a randomized, open-label, three-period study in a single center to see how a low-fat vs high-fat meal changes the pharmacokinetics of ABSK-011 capsules in 15 healthy participants, who receive four 50 mg capsules across three sessions with washouts. Part B is a fixed-sequence, open-label study in a single center to assess the effect of multiple days of omeprazole on ABSK-011 pharmacokinetics in another group of 15 healthy participants, starting with ABSK-011 after a low-fat meal. Blood samples for pharmacokinetic analysis are collected at multiple time points in Part A, and the design includes dosing on specified days across cycles. The trial uses ABSK-011 capsules and omeprazole enteric-coated tablets as interventions and is conducted under controlled, observational conditions to characterize drug–food and drug–drug interactions. Eligible participants are healthy adults ages 18–45 without significant medical history and who agree to contraception if applicable.

Why it matters

Potential benefit: If successful, results could guide dosing recommendations for ABSK-011 when taken with different meals or with proton pump inhibitors.

How similar studies have gone: Pharmacokinetic studies of drug interactions with meals and PPIs have been performed for similar compounds, providing precedent for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy subjects aged 18 to 45 years (inclusive) at screening;
2. Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
3. 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;
4. 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;
5. 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:

1. 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 ;
2. Known allergic history to food, environment, experimental drug ABSK-011 or other drugs;
3. 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;
4. have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011;
5. Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole, Rabeprazole, pantoprazole, etc.) within 14 days before the first dose;
6. 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;
7. For those who have used CYP2C19 inhibitors or inducers (including fluoxetine, fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part B only);
8. 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);
9. Patients with needle fainting, blood fainting history, or inability to tolerate venipunction, or difficulty in blood collection;
10. Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period);
11. 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;
12. 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.
13. 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;
14. 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;
15. 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;
16. 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;
17. 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);
18. had been vaccinated within 2 months prior to the first dose, or intended to be vaccinated throughout the study period;
19. 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.

Where it's running

  • Affiliated Hospital of Jiangnan University
    Wuxi, China
    Recruiting

Study contacts

  • Principal investigator: Yiqing Zhao, Bachelor — Affiliated Hospital of Jiangnan University
  • Study coordinator: Shuqi Zeng, Doctor
  • Email: clinical@abbisko.cn
  • Phone: +86-021-68910052

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.