A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects

NCT06694948 | Completed Phase 1

• 1 other identifier: ABSK021-108
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects 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

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 24 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 (the capsule is commercial formulation to be marketed) in period 1 day 1 and receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) 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 (the capsule was used in phase 3 study Part 1) in period 1 day 1 and receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) 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 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;
• 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, China

Location

Study Officials

• Yanhua Ding, 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: November 14, 2024
• First Posted: November 19, 2024
• Study Start: December 10, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 17, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)