Zanzalintinib for Liver Disease

Recruiting at 1 trial location

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exelixis

Disqualifiers: Cardiac events, Organ transplant, Encephalopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Medical Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

This trial is for adults with moderate liver dysfunction (Child-Pugh Class B) due to chronic, stable hepatic insufficiency with features of cirrhosis. Participants should not have donated blood recently and must match the age, sex, and smoking status ratios of others in the study. They need normal bone marrow function and no significant medical issues aside from liver impairment.

Inclusion Criteria

My bone marrow is functioning well.

I don't have any major health issues apart from my current condition.

I smoke 10 or fewer cigarettes a day and can limit it further during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of zanzalintinib tablet on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zanzalintinib

Trial Overview The study tests how a single dose of Zanzalintinib behaves in the body (its pharmacokinetics) among people with moderate liver problems compared to those with healthy livers. It aims to understand differences in drug processing due to liver function.

How Is the Trial Designed?

Group I: Moderate HI Experimental Treatment 1 Intervention

Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.

Group II: Matched Healthy Control Active Control 1 Intervention

Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD