NCT06962332PHASE1RecruitingAccepts Healthy Volunteers
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Exelixis
Start Date
5/13/2025
Completion Date
4/1/2026
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Interventions
DRUG
Zanzalintinib
Conditions
Hepatic ImpairmentModerate Hepatic Impairment
Locations
Exelixis Clinical Site #1
Orlando, Florida 32809
United States
Exelixis Clinical Site #2
San Antonio, Texas 78215
United States