Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaiichi Sankyo

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.

Male and female subjects 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.

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 means of contraception from Screening until 7 months after the dose of quizartinib 4. 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.

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quizartinib

    Drug

    Participants will receive a single oral dose of 30 mg

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Severe HIExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetic Parameter: Cmax

Maximum concentration, determined directly from individual concentration-time data

Time frame
From day of first dose, Day 1, through Day 29
2

Pharmacokinetic Parameter: Tmax

Time of the maximum concentration

Time frame
From day of first dose, Day 1, through Day 29
3

Pharmacokinetic Parameter: AUClast

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, through Day 29
4

Pharmacokinetic Parameter: AUCinf

Area under the concentration-time curve from time-zero extrapolated to infinity

Time frame
From day of first dose, Day 1, through Day 29

Secondary outcomes

1

Treatment Emergent Adverse Events

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 30 days after Day 29

Other outcomes

Sponsors and contacts

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