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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Quizartinib; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • WCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Male and female subjects 18 to 55 years of age (inclusive), with a BMI of 18 kg/m2 to 32 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
2. Has vital signs (measured after subject has been supine for at least 5 minutes) at Screening within the following ranges: heart rate: 50-100 beats per minute (bpm); systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once.
3. Liver function test results (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [TBil]) must be equal to or below the upper limit of normal.
4. Hemoglobin levels must ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
5. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram [documentation to confirm tubal occlusion 12 weeks after procedure]), postmenopausal status for at least 1 year (follicle stimulating hormone [FSH] > 40 mIU/mL serum and estradiol <40 pg/mL [<147 pmol/L] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the protocol-approved means of contraception from Screening until 7 months after the dose of quizartinib.
6. In males, documented surgical sterilization, or sexual abstinence, or agreement to use 1 of the protocol-approved means of contraception from Screening until 4 months after the single dose of quizartinib.

Key Exclusion Criteria:

1. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality) that could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
3. History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 milliseconds (ms) at Screening
4. Females who are pregnant or breastfeeding
5. Laboratory results (serum chemistry, hematology, and urinalysis) outside the normal range, if considered clinically significant by the investigator. Estimated creatinine clearance (CrCl) < 90 mL/min (calculated by Cockcroft-Gault equation) at Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Participants; All participants will receive either an oral dose of 90 mg of quizartinib or placebo on Day 1. On Day 2, all participants will receive the treatment that was not given on Day 1.	Drug: Quizartinib; Participants will receive a single oral dose of 90 mg; Other Names: VANFLYTA®; Other: Placebo; Participants will receive a single oral dose of 90 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Heart Rate	Day 1 and Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	TEAEs are defined as new AEs that occur after the first dose of study drug, including 14 days after last dose of study drug" to end of the sentence	From Day 1 up to the last day of Safety Follow-up (approximately 16 days)
Pharmacokinetic Parameter: Cmax	Maximum concentration, determined directly from individual concentration-time data	Days 1, 2 and 3
Pharmacokinetic Parameter: Tmax	Time of the maximum concentration	Days 1, 2 and 3
Pharmacokinetic Parameter: AUClast	Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down	Days 1, 2 and 3

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: quizartinib
• Additional Relevant MeSH Terms: Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Quizartinib
• Other Study ID Numbers: AC220-165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No