A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects

Launched by ABBISKO THERAPEUTICS CO, LTD · Mar 13, 2025

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy subjects aged 18 to 50 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. Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
• • 2. Known or persistent mental disorders;
• • 3. Past history of gastric or intestinal surgery, or other operations;
• • 4. Dysphagia and inability to take the investigational product orally;
• • 5. Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
• • 6. Known allergy to two or more kinds of foods and drugs; or allergic to pimicotinib or its excipients;and intolerance to dairy products;
• • 7. History of infection within 30 days prior to screening;
• • 8. Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
• • 9. Abnormal laboratory tests;
• • 10. Positive result for either of the following tests: serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, and treponema pallidum antibody;
• • 11. Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening;
• • 12. Previously participated in any other study related to pimicotinib and received pimicotinib;
• • 13. Used strong inhibitors or inducers of CYP3A4 within 14 days prior to screening and at Screening or intending to use during the study;
• • 14. Have special diet requirements and cannot accept to take a unified dietary;
• • 15. Consumption of more than 14 units of alcohol per week within 3 months prior to signing the informed consent form, or a positive result for alcohol breath test on the day pre-dose, or unable to abstain from alcohol during the study;
• • 16. Consumption of more than 5 cigarettes per day within 3 months prior to signing the informed consent form, or unable to abstain from tobacco products during the study;
• • 17. Previous chronic consumption of excessive amount of tea, coffee, or caffeinated beverages or unable to abstain from caffeinated beverages during the study;
• • 18. Known history of drug abuse or positive for drug abuse screening test;
• • 19. Used over the counter or prescription drugs within 14 days prior to screening, or plan to use such drugs during the study;
• • 20. Donated or lost \> 400 mL of blood within 3 months prior to screening; received blood transfusions or used blood products within 2 months prior to screening;
• • 21. Received vaccine within 2 months prior to screening, or plan to get vaccinated during the study;
• • 22. Significant abnormalities and judged by the investigator as clinical significance in vital signs;
• • 23. Heart rate-corrected QT interval prolongation;
• • 24. Subjects involved in the design or conduct of this study and their immediate family members;
• • 25. Subjects who, in the opinion of the investigator, are not suitable for enrollment or may not be able to complete the study for other reasons.

Trial Officials