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

NCT ID: NCT06962332

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2026-04-30

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.

Conditions

Hepatic Impairment; Moderate Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate HI

Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.

Group Type: EXPERIMENTAL

Zanzalintinib

Intervention Type: DRUG

Administered as specified in the treatment arm.

Matched Healthy Control

Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.

Group Type: ACTIVE_COMPARATOR

Zanzalintinib

Intervention Type: DRUG

Administered as specified in the treatment arm.

Interventions

Zanzalintinib

Administered as specified in the treatment arm.

Intervention Type: DRUG

Other Intervention Names

XL092

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Exelixis

Locations

Exelixis Clinical Site #1

Orlando, Florida, United States

Site Status: RECRUITING

Exelixis Clinical Site #2

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Exelixis Clinical Trials

Role: CONTACT

druginfo@exelixis.com

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

Backup or International

Role: CONTACT

650-837-7400

Other Identifiers

XL092-008

Identifier Type: -

Identifier Source: org_study_id