Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects

NCT06740825 | Completed Phase 1 FDA Drug

• 1 other identifier: AC220-164
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects

Conditions

Healthy Subjects

Keywords

Quizartinib

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic Parameter: Cmax

  Cmax is defined as maximum concentration, determined directly from individual concentration-time data

  From day of first dose, Day 1, up to Day 33

• Pharmacokinetic Parameter: AUClast

  AUClast is defined as area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down

  From day of first dose, Day 1, up to Day 33

• Pharmacokinetic Parameter: AUCinf

  AUCinf is defined as area under the concentration-time curve from time-zero extrapolated to infinity

  From day of first dose, Day 1, up to Day 33

Secondary Outcomes (1)

• Treatment Emergent Adverse Events (TEAEs)

  From day of first dose, Day 1 up to the last day of Safety Follow-up, up to approximately 40 days

Study Arms (2)

Treatment Group A (Test)

EXPERIMENTAL

On Day 1 through Day 32, participants will receive an oral dose of 400-mg of rufinamide twice daily (BID). In addition, on Day 12, subjects will receive an oral single dose of 60-mg quizartinib

Drug: Quizartinib; Drug: Rufinamide

Treatment Group B (Reference)

EXPERIMENTAL

On Day 1, participants will receive an oral dose of 60-mg quizartinib

Drug: Quizartinib

Interventions

Quizartinib DRUG

Single oral dose of 60 mg

Also known as: VANFLYTA®

Treatment Group A (Test); Treatment Group B (Reference)

Rufinamide DRUG

Twice daily (BID) dose of 400 mg on Days 1 through 32

Treatment Group A (Test)

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) 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 \[TBbil\]) must be equal to or below the upper limit of normal (ULN). Hemoglobin levels must be ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
• In females, documented surgical sterilization (i.e., 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 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 dose of quizartini

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.
• History of a clinically significant illness, in the opinion of the Investigator, 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 using the 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; rufinamide

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: October 29, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)