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โ† Trials
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Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)

RecruitingPhase 1Ages 18 Years - 75 YearsAllExelixis
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * 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 โ‰ค 10 cigarettes, โ‰ค 2 cigars, or โ‰ค2 pipes per day and agree to limit smoking during the confinement period to โ‰ค 4 cigarettes or โ‰ค1 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. * 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 โ‰ค 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 ยฑ 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. Key Exclusion Criteria: * All Participants: * โ€ข 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. * 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.
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What it tests

  • Zanzalintinib
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Where

2 sites
Exelixis Clinical Site #1
Orlando, United States
Exelixis Clinical Site #2
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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