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

NCT ID: NCT06562946

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-01-10

Brief Summary

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pimicotinib

Intervention Type: DRUG

Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

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.

Group Type: EXPERIMENTAL

Pimicotinib

Intervention Type: DRUG

Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

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.

Group Type: EXPERIMENTAL

Pimicotinib

Intervention Type: DRUG

Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

Interventions

Pimicotinib

Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbisko Therapeutics Co, Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanan Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The first hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

ABSK021-106

Identifier Type: -

Identifier Source: org_study_id