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

Last updated: June 17, 2025
Sponsor: Exelixis
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Zanzalintinib

Clinical Study ID

NCT06962332
XL092-008
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • All Participants:

  • No clinically significant medical history (aside from the HI for participantsin the HI group only), physical examination findings, or vital signs, as deemedby the investigator.

  • A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2cigars, or ≤2 pipes per day and agree to limit smoking during the confinementperiod to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree tomaintain the same smoking status (smoker or non-smoker) from screening anduntil after the last PK sample collection.

  • Has not donated blood within 30 days of dosing or plasma within 7 days ofdosing and must agree to refrain from blood donation until at least 30 daysfollowing 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 withinthe range of > 1.5* upper limit of normal (ULN) and ≤ 3* ULN at the screeningand dosing visit.

  • Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illnesswithin the previous 2 months due to deterioration in hepatic function) hepaticinsufficiency at the screening visit with features of cirrhosis due to anyetiology.

  • 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 statusratio of participants with moderate HI.

Exclusion

Key Exclusion Criteria:

  • All Participants:

  • • History of any medical or surgical conditions that would potentially alterabsorption, distribution, metabolism, and/or excretion of orally administereddrugs.

  • 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 thechange of more than 1 Child-Pugh point) within 30 days prior to Day 1, in theopinion of the investigator and Sponsor.

  • Symptoms or history of Grade 3 or worse degree of encephalopathy within 3months 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 todosing.

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Zanzalintinib
Phase: 1
Study Start date:
May 13, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Exelixis Clinical Site #1

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Exelixis Clinical Site #2

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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