NCT06562946

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2024-09-20
• Primary completion: 2024-12-30
• Completion: 2025-01-10
• First posted: 2024-08-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: China