Quizartinib for Liver Disease

Recruiting at 2 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Disqualifiers: Primary biliary cirrhosis, Gilbert's syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

Trial Summary

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.

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.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

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.

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Severe HI Experimental Treatment 1 Intervention

Participants will receive a single oral dose of 30 mg quizartinib

Group II: Control Group Experimental Treatment 1 Intervention

Healthy participants will receive a single oral dose of 30 mg quizartinib

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

Approved in United States as Vanflyta for:

• Acute myeloid leukemia (AML)

Approved in Japan as Vanflyta for:

• Acute myeloid leukemia (AML)

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD