RECRUITING

Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)

Conditions

Hepatic Impairment Moderate Hepatic Impairment Zanzalintinib Pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment

Quick Facts

Study Start:2025-05-13

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06962332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Exelixis Clinical Trials

CONTACT

1-888-EXELIXIS (888-393-5494)

druginfo@exelixis.com

Backup or International

CONTACT

650-837-7400

Principal Investigator

Medical Director

STUDY_DIRECTOR

Exelixis

Study Locations (Sites)

Exelixis Clinical Site #1

Orlando, Florida, 32809

United States

Exelixis Clinical Site #2

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Exelixis

Medical Director, STUDY_DIRECTOR, Exelixis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-05-13

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Zanzalintinib
Pharmacokinetics

Additional Relevant MeSH Terms

Hepatic Impairment
Moderate Hepatic Impairment