A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function
Daiichi Sankyo
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.
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugQuizartinib
Participants will receive a single oral dose of 30 mg
Locations (3)
- Clinical Pharmacology of Miami, LLCMiami, Florida
- Advanced PharmaMiami, Florida
- GCP ResearchSt. Petersburg, Florida