The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function

An Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function

This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Pimicotinib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects should understand the study procedures and sign the informed consent form prior to Screening.
2. Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 18 and 32 (inclusive), BMI = weight (kg)/height (m)2.
4. Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).

Exclusion Criteria:

1. Known allergy or hypersensitivity to any components of the investigational drug product;
2. Has a history of cancer in five years (malignancy), exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinomas in situ;
3. Has factors that significantly affect the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small bowel resection, etc.
4. Has a history of portosystemic shunt.
5. Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
6. Received live vaccines or live-attenuated virus vaccine within 3 months prior to screening, or plan to get vaccinated during the study;
7. Previously participated in this study or any other study related to pimicotinib and received pimicotinib;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The mild (Child-Pugh score 5 to 6) hepatic impairment.; Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib; Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.
Experimental: The moderate (Child-Pugh score 7 to 9) hepatic impairment.; Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib; Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.
Experimental: The healthy subjects.; Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib; Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUClast	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUC 0-∞	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol

Collaborators and Investigators

• Sponsor: Abbisko Therapeutics Co, Ltd
• Investigators: Principal Investigator: Yanan Wang, Doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 18, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ABSK021-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No