Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects
Lead Sponsor:
Abbisko Therapeutics Co, Ltd
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign th...
Eligibility Criteria
Inclusion
- Healthy subjects aged 18 to 50 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
- Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
- Known or persistent mental disorders;
- Past history of gastric or intestinal surgery, or other operations;
- Dysphagia and inability to take the investigational product orally;
- Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
- Known allergy to two or more kinds of foods and drugs; or allergic to pimicotinib or its excipients;and intolerance to dairy products;
- History of infection within 30 days prior to screening;
- Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
- Abnormal laboratory tests;
- 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;
- Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening;
- Previously participated in any other study related to pimicotinib and received pimicotinib;
- Used strong inhibitors or inducers of CYP3A4 within 14 days prior to screening and at Screening or intending to use during the study;
- Have special diet requirements and cannot accept to take a unified dietary;
- 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;
- 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;
- Previous chronic consumption of excessive amount of tea, coffee, or caffeinated beverages or unable to abstain from caffeinated beverages during the study;
- Known history of drug abuse or positive for drug abuse screening test;
- Used over the counter or prescription drugs within 14 days prior to screening, or plan to use such drugs during the study;
- 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;
- Received vaccine within 2 months prior to screening, or plan to get vaccinated during the study;
- Significant abnormalities and judged by the investigator as clinical significance in vital signs;
- Heart rate-corrected QT interval prolongation;
- Subjects involved in the design or conduct of this study and their immediate family members;
- 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.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06884072
Start Date
April 8 2025
End Date
August 1 2025
Last Update
April 20 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000