A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects

NCT07210996 | Completed Phase 1

• 1 other identifier: ABSK021-113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, two-treatment, single-dose, two-way crossover study to evaluate the relative bioavailability and tolerability of Pimicotinib capsules containing free base in different proportions in healthy participants. 20 healthy participants are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B.Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

Conditions

Pharmacokinetics in Healthy Volunteers

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, 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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.

• AUClast

  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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.

Secondary Outcomes (4)

• AE

  through study completion, an average of 26 days

• t1/2

  Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 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, 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, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours

Study Arms (2)

pimicotinib (test capsule-reference capsule)

OTHER

subjects in sequence A will receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (free base content at certain level) in period 1 day 1 and receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (free base content below detection limit) in period 2 day 1.

Drug: pimicotinib capsules

pimicotinib (reference capsule-test capsule)

OTHER

subjects in sequence B will receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg ((free base content below detection limit) in period 1 day 1 and receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (free base content at certain level) in period 2 day 1 .

Drug: pimicotinib capsules

Interventions

pimicotinib capsules DRUG

pimicotinib capsules

pimicotinib (reference capsule-test capsule); pimicotinib (test capsule-reference capsule)

Eligibility Criteria

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

You may qualify if:

• Healthy participants aged 18 to 50 years (inclusive) at screening and at least 25% of each sex should be included.
• Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female), with a body mass index (BMI) between 18 and 28 (inclusive), BMI = weight (kg)/height (m)2;
• 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 participants 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 , and male participants should not donate sperm during such period; female participants should not donate ovum during such period and should not be pregnant or lactating. Pregnancy period is defined as the period from the date of conception until termination of pregnancy, and will be determined by laboratory test of human chorionic gonadotropin (hCG) within 7 days prior to initiation of the study;
• 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 that may preclude the subject from participation in the study, as determined by the investigator;
• Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption;
• 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 (lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, gelatin); and prone to allergic reactions such as rash and urticaria;
• History of bacterial, fungal, parasitic, viral (excluding nasopharyngitis), mycobacterial infection, and COVID-19 infection within 30 days prior to screening; or abnormal chest X-ray (posteroanterior view) finding, assessed as clinically significant (by the investigator);
• Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
• Abnormal laboratory tests: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 1.2 × Upper Limit of Normal (ULN); Creatinine \> 1.2 × ULN; Total Bilirubin (TBIL) \> 1.5 × ULN; Creatine Kinase (CK) \> 1.5 × ULN and amylase \> 1.2 × ULN; hemoglobin \<115g/L for Male or \< 105g/L for Female;
• 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; specific dietary requirements the participants can only eat the food provided by the study site during hospitalization;
• 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, China

Location

Study Officials

• Xiaojiao Li, Doctor

  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: September 30, 2025
• First Posted: October 7, 2025
• Study Start: September 12, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 16, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)