NCT06740799

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

Detailed description

This is a clinical pharmacology study with 2 cohorts (subjects with severe HI by Child-Pugh criteria and matched healthy control subjects) to evaluate the PK, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe HI (as defined by Child-Pugh criteria). This study is planned to be conducted at up to 3 sites in the US, which use Child-Pugh criteria.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Quizartinib	Participants will receive a single oral dose of 30 mg

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-12-18
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study