NCT06772246

A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

A Single Blind, Fixed Sequence, Single-dose Study to Evaluate the Serious Risk of QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.

Detailed description

This is a QT assessment study of quizartinib when given as a single oral dose of 90 mg in 70 healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Quizartinib	Participants will receive a single oral dose of 90 mg
OTHER	Placebo	Participants will receive a single oral dose of 90 mg

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2025-01-13
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study