Daiichi Sankyo
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
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.
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 \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenop…
Participants will receive a single oral dose of 30 mg
Arctuva estimate
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