Status:
RECRUITING
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Lead Sponsor:
Exelixis
Conditions:
Hepatic Impairment
Moderate Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 no...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06962332
Start Date
May 13 2025
End Date
April 1 2026
Last Update
June 22 2025
Active Locations (2)
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1
Exelixis Clinical Site #1
Orlando, Florida, United States, 32809
2
Exelixis Clinical Site #2
San Antonio, Texas, United States, 78215