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

NCT06772246 | Completed Phase 1 FDA Drug

• 1 other identifier: AC220-165
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

quizartinib

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate

  Day 1 and Day 2

Secondary Outcomes (4)

• Treatment Emergent Adverse Events (TEAEs)

  From Day 1 up to the last day of Safety Follow-up (approximately 16 days)

• Pharmacokinetic Parameter: Cmax

  Days 1, 2 and 3

• Pharmacokinetic Parameter: Tmax

  Days 1, 2 and 3

• Pharmacokinetic Parameter: AUClast

  Days 1, 2 and 3

Study Arms (1)

Healthy Participants

EXPERIMENTAL

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; Other: Placebo

Interventions

Quizartinib DRUG

Participants will receive a single oral dose of 90 mg

Also known as: VANFLYTA®

Healthy Participants

Placebo OTHER

Participants will receive a single oral dose of 90 mg

Healthy Participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• Hemoglobin levels must ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
• 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.
• 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.

You may not qualify if:

• 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.
• In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
• 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
• Females who are pregnant or breastfeeding
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

WCT

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

quizartinib

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-blinded study where only the participants will be blinded to the treatment being administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 13, 2025
• Study Start: October 24, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)