Hepatic Impairment
Conditions
Keywords
quizartinib
Brief summary
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
Detailed description
This is a clinical pharmacology study with 2 cohorts (subjects with severe HI by Child-Pugh criteria and matched healthy control subjects) to evaluate the PK, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe HI (as defined by Child-Pugh criteria). This study is planned to be conducted at up to 3 sites in the US, which use Child-Pugh criteria.
Interventions
DRUGQuizartinib
Participants will receive a single oral dose of 30 mg
Sponsors
Daiichi Sankyo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking,
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. 2. 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. 3. 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. 5\. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib Key Exclusion: 1. 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. 2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib. 3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis. 4. Subjects with history of Gilbert's syndrome. 5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib. 6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter: Cmax | From day of first dose, Day 1, through Day 29 | Maximum concentration, determined directly from individual concentration-time data |
| Pharmacokinetic Parameter: Tmax | From day of first dose, Day 1, through Day 29 | Time of the maximum concentration |
| Pharmacokinetic Parameter: AUClast | From day of first dose, Day 1, through Day 29 | Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down |
| Pharmacokinetic Parameter: AUCinf | From day of first dose, Day 1, through Day 29 | Area under the concentration-time curve from time-zero extrapolated to infinity |
| Pharmacokinetic Parameter: t1/2 | From day of first dose, Day 1, through Day 29 | The observed terminal half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | From day of first dose, Day 1, up to 30 days after Day 29 | TEAEs are defined as new AEs that occur after the first dose of study drug |
Countries
United States
Contacts
CONTACTDaiichi Sankyo Contact for Clinical Trial Information
STUDY_DIRECTORGlobal Clinical Leader
Daiichi Sankyo
Outcome results
None listed