Clinical trial NCT06562946: The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Abbisko Therapeutics Co, Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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;

Primary outcomes:
measure: Cmax
timeFrame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
measure: AUClast
timeFrame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
measure: AUC 0-∞
timeFrame: Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanan Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: