Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExelixis
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Adequate bone marrow function, at the screening and dosing visit.
Disqualifiers
• 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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Zanzalintinib
DrugAdministered as specified in the treatment arm.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Moderate HIExperimental treatment 1 intervention
Group B: Matched Healthy ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 postdose2
Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib
Time frame
Predose up to 7 days postdose3
Time to Cmax (Tmax) of Zanzalintinib
Time frame
Predose up to 7 days postdoseSecondary outcomes
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to 30 days Source ClinicalTrials.gov