Actively Recruiting
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Led by Exelixis · Updated on 2025-06-22
20
Participants Needed
2
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No significant medical history or physical exam findings besides hepatic impairment for HI group only
- Non-smoker or moderate smoker (≤10 cigarettes, ≤2 cigars, or ≤2 pipes daily) who agrees to limit smoking during the study
- No blood donation within 30 days before dosing and agrees to avoid donation until 30 days after dosing
- Adequate bone marrow function at screening and dosing visits (HI group only)
- Classified as moderate hepatic impairment by Child-Pugh Class B (score 7 to 9) with total bilirubin >1.5 to ≤3 times upper limit of normal (HI group only)
- Diagnosis of chronic (>6 months), stable hepatic insufficiency with cirrhosis features (HI group only)
- Healthy controls matched in age (±10 years), sex ratio, and smoking status ratio to HI group
You will not qualify if you...
- Medical or surgical conditions that affect drug absorption, distribution, metabolism, or excretion
- Risk or history of major cardiac events or dysfunction
- History of liver or other solid organ transplant (HI group only)
- Fluctuating or rapidly worsening hepatic function within 30 days prior to Day 1 (HI group only)
- Grade 3 or worse encephalopathy symptoms or history within 3 months before dosing (HI group only)
- Severe ascites observed at screening or check-in (HI group only)
- History or presence of alcohol or drug abuse within 2 years prior to dosing (healthy controls)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Exelixis Clinical Site #1
Orlando, Florida, United States, 32809
Actively Recruiting
2
Exelixis Clinical Site #2
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
E
Exelixis Clinical Trials
CONTACT
B
Backup or International
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here