Recruiting
Phase 1

Zanzalintinib

Sponsor:

Exelixis

Code:

NCT06962332

Conditions

Hepatic Impairment

Moderate Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Zanzalintinib

Study Details

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 ID

NCT06962332

Start date

May 13, 2025

Status verified date

Jun, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate HI

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

active comparator: Matched Healthy Control

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

Interventions

Zanzalintinib

Administered as specified in the treatment arm.

Primary outcome measure

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib [ Time Frame: Predose up to 7 days postdose ]
  • Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib [ Time Frame: Predose up to 7 days postdose ]
  • Time to Cmax (Tmax) of Zanzalintinib [ Time Frame: Predose up to 7 days postdose ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

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

Backup or International

650-837-7400

Locations

Exelixis Clinical Site #1

Recruiting

Orlando, Florida, United States, 32809

Exelixis Clinical Site #2

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Exelixis

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • Zanzalintinib
  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Exelixis on 2025-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.