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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Exelixis
Study ID
NCT06962332
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment
  • Moderate Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Zanzalintinib — DRUG
    Administered as specified in the treatment arm.

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

  • Exelixis Clinical Trials
    1-888-EXELIXIS (888-393-5494)
    [email protected]
  • Backup or International
    650-837-7400

Locations (2)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #1OrlandoFlorida32809-
Exelixis Clinical Site #2San AntonioTexas78215-

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