Phase
Condition
Primary Biliary Cholangitis
Treatment
Zanzalintinib
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
All Participants:
No clinically significant medical history (aside from the HI for participantsin the HI group only), physical examination findings, or vital signs, as deemedby the investigator.
A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2cigars, or ≤2 pipes per day and agree to limit smoking during the confinementperiod to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree tomaintain the same smoking status (smoker or non-smoker) from screening anduntil after the last PK sample collection.
Has not donated blood within 30 days of dosing or plasma within 7 days ofdosing and must agree to refrain from blood donation until at least 30 daysfollowing 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 withinthe range of > 1.5* upper limit of normal (ULN) and ≤ 3* ULN at the screeningand dosing visit.
Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illnesswithin the previous 2 months due to deterioration in hepatic function) hepaticinsufficiency at the screening visit with features of cirrhosis due to anyetiology.
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 statusratio of participants with moderate HI.
Exclusion
Key Exclusion Criteria:
All Participants:
• History of any medical or surgical conditions that would potentially alterabsorption, distribution, metabolism, and/or excretion of orally administereddrugs.
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 thechange of more than 1 Child-Pugh point) within 30 days prior to Day 1, in theopinion of the investigator and Sponsor.
Symptoms or history of Grade 3 or worse degree of encephalopathy within 3months 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 todosing.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Exelixis Clinical Site #1
Orlando, Florida 32809
United StatesActive - Recruiting
Exelixis Clinical Site #2
San Antonio, Texas 78215
United StatesActive - Recruiting
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