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Completed

NCT Number: NCT06562946

The 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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The first hospital of Jilin University

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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;

Treatment and study plan

Pimicotinib

Drug

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

Primary outcomes

  1. Cmax

    Time frame: 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.

  2. AUClast

    Time frame: 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.

  3. AUC 0-∞

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbisko Therapeutics Co, Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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