Clinical trial NCT06884072: A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects
Official title: A Phase 1, Open-label, Randomized, Single Dose, 2-Treatment, 2-Sequence, 2-Period Crossover Study to Evaluate the Effect of a High-fat Meal on the Exposures of Pimicotinib Capsule in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Abbisko Therapeutics Co, Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 them to either Study Sequence A or Study Sequence B. Subjects in Sequence A will take a single 50 - milligram oral dose of Pimicotinib capsules in a post - high - fat - meal state during Phase 1. Subjects in Sequence B will take a single 50 - milligram oral dose of Pimicotinib capsules in a fasting state during Phase 1 and then receive cross - over administration in Phase 2. In total, blood samples will be collected at 34 time points for pharmacokinetic (PK) analysis.


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.

Primary outcomes:
measure: Cmax
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
measure: AUC0-∞
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
measure: AUC last
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Secondary outcomes:
measure: t1/2
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
measure: CL/F
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
measure: Vz/F
timeFrame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
measure: AE
timeFrame: through study completion, an average of 26 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Xiaojiao Li
role: PRINCIPAL_INVESTIGATOR
References: