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CompletedNCT06740825Updated Dec 18, 2024

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

A Phase 1 interventional study of Quizartinib and Rufinamide in Healthy Subjects, sponsored by Daiichi Sankyo. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2024, 1 year 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a clinical pharmacology study with 2 treatment groups (Test treatment group receiving both rufinamide weak CYP3A inducer and quizartinib and Reference treatment group receiving quizartinib only) investigating the effect of rufinamide on the PK of quizartinib in healthy subjects.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Quizartinib
03

In context

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Treatment Group A (Test)

    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

  • Experimental
    Treatment Group B (Reference)

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

    Drug: Quizartinib

Interventions

  • DrugQuizartinib

    Single oral dose of 60 mg

    Also known as: VANFLYTA®

  • DrugRufinamide

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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic Parameter: Cmax

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

    Time frame: From day of first dose, Day 1, up to Day 33

  2. 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

    Time frame: From day of first dose, Day 1, up to Day 33

  3. Pharmacokinetic Parameter: AUCinf

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

    Time frame: From day of first dose, Day 1, up to Day 33

Secondary outcomes

  1. Treatment Emergent Adverse Events (TEAEs)

    TEAEs are defined as new AEs that occur after the first dose of study drug

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

07

Study locations

1 site
  • WCT
    San Antonio, Texas 78217, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06740825
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Dec 18, 2024
Start date
Oct 29, 2024
Primary completion
Dec 9, 2024
Completion
Dec 9, 2024
Last update
Dec 18, 2024

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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