NCT06962332 Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
| NCT ID | NCT06962332 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Exelixis |
| Condition | Hepatic Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-05-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 normal liver function.
Eligibility Criteria
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Exelixis
Frequently Asked Questions
Who can join the NCT06962332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatic Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06962332 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06962332 currently recruiting?
Yes, NCT06962332 is actively recruiting participants. Contact the research team at druginfo@exelixis.com for enrollment information.
Where is the NCT06962332 trial being conducted?
This trial is being conducted at Orlando, United States, San Antonio, United States.
Who is sponsoring the NCT06962332 clinical trial?
NCT06962332 is sponsored by Exelixis. The principal investigator is Medical Director at Exelixis. The trial plans to enroll 20 participants.