12 Participants Needed

Quizartinib for Liver Disease

Recruiting at 2 trial locations
DS
Overseen ByDaiichi Sankyo Contact for Clinical Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Daiichi Sankyo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Who Is on the Research Team?

GC

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-75 with severe liver impairment, a BMI of 18-37, and at least 40 kg in weight. Women must not undergo egg retrieval or donate eggs during the study and for seven months after. Men must use contraception or be surgically sterilized. Participants cannot have certain liver diseases, serious medical conditions that could affect the study's safety or results, recent significant illness, known allergies to Quizartinib ingredients, or a history of digestive surgery affecting drug absorption.

Inclusion Criteria

In females, agreement to not retrieve eggs/ova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later
Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures
I am a male and have been sterilized, practice abstinence, or agree to use contraception during and up to 4 months after treatment.
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Exclusion Criteria

I have been diagnosed with primary biliary cirrhosis or primary sclerosing cholangitis.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results
I haven't had a serious illness in the last 4 weeks.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of 30 mg quizartinib

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability

30 days
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Quizartinib
Trial Overview The trial is testing Quizartinib pharmacokinetics (how the drug moves through the body) in subjects with severe hepatic impairment compared to healthy individuals. It aims to understand how liver disease affects the processing of this medication.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Severe HIExperimental Treatment1 Intervention
Group II: Control GroupExperimental Treatment1 Intervention

Quizartinib is already approved in United States, Japan for the following indications:

🇺🇸
Approved in United States as Vanflyta for:
🇯🇵
Approved in Japan as Vanflyta for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

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