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

NCT06884072 | Active Not Recruiting Phase 1

• 1 other identifier: ABSK021-111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax

  Peak concentration, the maximum observed plasma concentration of pimicotinib

  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.

• AUC0-∞

  Area under the plasma concentration-time curve of pimicotinib from time 0 to infinity, calculated as: AUC0-∞=AUClast +Clast/λz; Clast refers to the last measurable (non-BQL) plasma concentration of pimicotinib.

  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.

• AUC last

  Area under the plasma concentration-time curve of pimicotinib from time 0 to the time of last measurable (non-BQL) concentration (calculated using the Linear Up Log Down trapezoidal method)

  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 (4)

• t1/2

  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.

• CL/F

  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.

• Vz/F

  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.

• AE

  through study completion, an average of 26 days

Study Arms (2)

Sequence A: Pimicotinib 50mg (2x25mg) - High - fat Meal First, Then Fasting

EXPERIMENTAL

Subjects in Sequence A will be administered a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 1, and a single oral dose of 50 mg Pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 2.

Drug: Pimicotinib capsule

Sequence B: Pimicotinib 50mg (2x25mg) - Fasting First, Then High - fat Meal

EXPERIMENTAL

Subjects in Sequence B will receive a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a fasting state on Day 1 of Period 1, and a single oral dose of 50 mg pimicotinib capsules (2 x 25 mg) in a post-high-fat meal state on Day 1 of Period 2.

Drug: Pimicotinib capsule

Interventions

Pimicotinib capsule DRUG

Pimicotinib capsule

Sequence A: Pimicotinib 50mg (2x25mg) - High - fat Meal First, Then Fasting; Sequence B: Pimicotinib 50mg (2x25mg) - Fasting First, Then High - fat Meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Officials

• Xiaojiao Li

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 8, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)