Hepatic ImpairmentPhase 1NCT06962332
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
A Phase 1 study testing Zanzalintinib in people with Hepatic Impairment and Moderate Hepatic Impairment, run by Exelixis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Moderate Hepatic Impairment
- What is being tested?
- Zanzalintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2025to Apr 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Backup or International contact
United States2 sites, 2 recruiting
- Recruiting
Exelixis Clinical Site #1
Orlando, Florida, 32809
- Recruiting
Exelixis Clinical Site #2
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment
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
- Being tested
- Zanzalintinib
- Keywords
- Zanzalintinib, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL092
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Moderate HI | Experimental | Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1. Receives: Drug: Zanzalintinib |
| Matched Healthy Control | Active comparator | Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1. Receives: Drug: Zanzalintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib
Measured: Predose up to 7 days postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib
Measured: Predose up to 7 days postdose
Time to Cmax (Tmax) of Zanzalintinib
Measured: Predose up to 7 days postdose
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start13 May 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962332
- Sponsor's protocol ID
- XL092-008
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No