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

NCT06562946 | Completed Phase 1

• 1 other identifier: ABSK021-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

The mild (Child-Pugh score 5 to 6) hepatic impairment.

EXPERIMENTAL

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

The moderate (Child-Pugh score 7 to 9) hepatic impairment.

EXPERIMENTAL

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

The healthy subjects.

EXPERIMENTAL

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

Interventions

Pimicotinib DRUG

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

The healthy subjects.; The mild (Child-Pugh score 5 to 6) hepatic impairment.; The moderate (Child-Pugh score 7 to 9) hepatic impairment.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects should understand the study procedures and sign the informed consent form prior to Screening.
• Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
• 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.
• Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).

You may not qualify if:

• Known allergy or hypersensitivity to any components of the investigational drug product;
• 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;
• 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.
• Has a history of portosystemic shunt.
• Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
• Received live vaccines or live-attenuated virus vaccine within 3 months prior to screening, or plan to get vaccinated during the study;
• Previously participated in this study or any other study related to pimicotinib and received pimicotinib;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

Location

Study Officials

• Yanan Wang, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: September 20, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 10, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)