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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Pimicotinib

• Registration Number: NCT06562946
• Lead Sponsor: Abbisko Therapeutics Co, Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-18
• Study First Posted: 2024-08-20
• Study Start: 2024-09-20
• Primary Completion: 2024-12-30
• Status Verified: 2025-01
• Study Completion: 2025-01-10
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The moderate (Child-Pugh score 7 to 9) hepatic impairment.	Pimicotinib	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.
The mild (Child-Pugh score 5 to 6) hepatic impairment.	Pimicotinib	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.
The healthy subjects.	Pimicotinib	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.

Primary Outcome Measures

Name	Time	Method
AUClast	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol	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.
Cmax	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol	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.
AUC 0-∞	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol	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.

Trial Locations

Locations (1)

The first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China