Zanzalintinib Study for Moderate Liver Impairment
This study is looking at how the body handles a single dose of zanzalintinib in people with moderate liver impairment (hepatic impairment) compared to healthy individuals. Researchers want to understand how much of the drug gets into the bloodstream and how long it stays there. This information helps determine the right dose for people with liver problems. You may be able to join if you are between 18 and 75 years old and have moderate liver impairment or normal liver function. The study aims to enroll 20 participants. The study's current recruitment status is unclear.
- Study design
- This interventional study aims to enroll 20 participants. It compares how zanzalintinib is processed in people with moderate liver impairment versus healthy individuals.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures drug levels in your body from before the dose up to 7 days after the dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06962332
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Recruiting
PHASE1Ages 18–75InterventionalTreatmentExelixis
~20 participants
Updated 2025-06-22 on ClinicalTrials.gov
What's tested:Zanzalintinib
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib
Measured over Predose up to 7 days postdose
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesFlorida1
Texas1
Study leadership
- Medical Director · STUDY_DIRECTOR · Exelixis
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
All Participants:
No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.
A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.
Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.
Participants with Moderate HI Only:
Adequate bone marrow function, at the screening and dosing visit.
Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \> 1.5\* upper limit of normal (ULN) and ≤ 3\* ULN at the screening and dosing visit.
Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at the screening visit with features of cirrhosis due to any etiology.
Healthy Control Participants Only:
Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male/female ratio), and smoking status ratio (smokers/non-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.
Exclusion
All Participants:
• History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs.
Has or is at risk for major cardiac events or dysfunction.
Participants with Moderate HI Only:
History of liver or other solid organ transplant.
Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.
Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.
Clinical evidence of severe ascites at the screening visit or at check in.
Healthy Control Participants Only:
History or presence of alcohol or drug abuse within the past 2 years prior to dosing.
What this trial measures
- Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of ZanzalintinibPredose up to 7 days postdose
- Maximum Observed Plasma Drug Concentration (Cmax) of ZanzalintinibPredose up to 7 days postdose
- Time to Cmax (Tmax) of ZanzalintinibPredose up to 7 days postdose