Status:
COMPLETED
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
Lead Sponsor:
Abbisko Therapeutics Co, Ltd
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06562946
Start Date
September 20 2024
End Date
January 10 2025
Last Update
January 20 2025
Active Locations (1)
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1
The first hospital of Jilin University
Changchun, Jilin, China