Menu
Recruiting NCT06962332

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

Phase I Interventional Hepatic Impairment Moderate Hepatic Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanzalintinib.
Who it may be relevant to
Registry conditions: Hepatic Impairment, Moderate Hepatic Impairment. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Zanzalintinib
    Administered as specified in the treatment arm.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 30 days]

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Exelixis Clinical Site #1 — Orlando
  • Exelixis Clinical Site #2 — San Antonio

Identifiers

NCT: NCT06962332 · XL092-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗