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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Abbisko Therapeutics Co, Ltd Industry-sponsored |
| Locations | 1 site (Wuxi) |
| Status | Recruiting |
| Started | July 21, 2026 |
| Main results expected | August 10, 2026 |
| Study ends | August 10, 2026 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07700953 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How age affects germinal center responses after flu and rabies vaccines
Researchers will test how the immune system responds to flu and rabies vaccines in younger adults (18–40) and older adults (65+).
-
Magnetic field maps with NV sensors for non-invasive heart measurements
This study tests whether diamond-based NV magnetometers can non-invasively detect and map the heart's magnetic field in healthy adults.
-
Methylation analyses using home-based self-sampling in women with and without gynecological disease
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation markers that distinguish people with gynecological (pre-)cancers from cancer-free controls.
-
Omega-3 status in healthy adults: comparing different fish-oil and algae-oil products
This study tests whether various fish-oil and algae-oil products can raise the Omega-3 Index in healthy adults who don’t eat much fatty fish.
-
A safe, carefully dosed test of TBD11 in healthy adults
This phase 1 study tests TBD11 in healthy adults to see if it is safe and tolerable and to understand how it behaves in the body, including how it interacts with other medicines.
-
Fosmanogepix in healthy adults: how it may interact with other drugs and heart rhythm
This study tests whether fosmanogepix (and its active form manogepix) changes how other medicines work in healthy adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.