Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
NCT06962332 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-06-22
Summary
The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.
Conditions
- Hepatic Impairment
- Moderate Hepatic Impairment
Interventions
- DRUG
-
Zanzalintinib
Administered as specified in the treatment arm.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Exelixis
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-13
- Primary Completion
- 2025-12-31
- Completion
- 2026-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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