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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06962332
- Acronym / sponsor ID
- XL092-008
- Conditions
- Hepatic Impairment, Moderate Hepatic Impairment
- Keywords
- Zanzalintinib, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate HI | Experimental | Drug: ZanzalintinibParticipants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1. |
| Matched Healthy Control | Active comparator | Drug: ZanzalintinibMatched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All Participants:
- Participants with Moderate HI Only:
- Healthy Control Participants Only:
Key exclusion criteria (11 listed)
- All Participants:
- Participants with Moderate HI Only:
- Healthy Control Participants Only:
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanzalintinibAlso: XL092Administered as specified in the treatment arm. | Drug | Matched Healthy Control, Moderate HI |
Primary outcome
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
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Backup or International contact
Medical Director study director
Exelixis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanzalintinib in people with Hepatic Impairment and Moderate Hepatic Impairment, run by Exelixis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Exelixis Clinical Trials (1-888-EXELIXIS (888-393-5494), druginfo@exelixis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.