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

NCT06962332 | Recruiting Phase 1 FDA Drug

• 1 other identifier: XL092-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

Zanzalintinib; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib

  Predose up to 7 days postdose

• Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib

  Predose up to 7 days postdose

• Time to Cmax (Tmax) of Zanzalintinib

  Predose up to 7 days postdose

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 30 days

Study Arms (2)

Moderate HI

EXPERIMENTAL

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

Drug: Zanzalintinib

Matched Healthy Control

ACTIVE COMPARATOR

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

Drug: Zanzalintinib

Interventions

Zanzalintinib DRUG

Administered as specified in the treatment arm.

Also known as: XL092

Matched Healthy Control; Moderate HI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (2)

Exelixis Clinical Site #1

Orlando, Florida, 32809, United States

RECRUITING

Exelixis Clinical Site #2

San Antonio, Texas, 78215, United States

RECRUITING

Study Officials

• Medical Director

  Exelixis

  STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

1-888-EXELIXIS (888-393-5494); druginfo@exelixis.com

Backup or International

CONTACT

650-837-7400

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)