Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06962332
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Predose up to 7 days postdose'}, {'measure': 'Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib', 'timeFrame': 'Predose up to 7 days postdose'}, {'measure': 'Time to Cmax (Tmax) of Zanzalintinib', 'timeFrame': 'Predose up to 7 days postdose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zanzalintinib', 'Pharmacokinetics'], 'conditions': ['Hepatic Impairment', 'Moderate Hepatic Impairment']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* All Participants:\n\n * 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.\n * 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.\n * 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.\n* Participants with Moderate HI Only:\n\n * Adequate bone marrow function, at the screening and dosing visit.\n * 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.\n * 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.\n* Healthy Control Participants Only:\n\n * 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.\n\nKey Exclusion Criteria:\n\n* All Participants:\n\n * • History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs.\n * Has or is at risk for major cardiac events or dysfunction.\n* Participants with Moderate HI Only:\n\n * History of liver or other solid organ transplant.\n * 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.\n * Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.\n * Clinical evidence of severe ascites at the screening visit or at check in.\n* Healthy Control Participants Only:\n\n * History or presence of alcohol or drug abuse within the past 2 years prior to dosing.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06962332', 'briefTitle': 'Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exelixis'}, 'officialTitle': 'A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment', 'orgStudyIdInfo': {'id': 'XL092-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate HI', 'description': 'Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.', 'interventionNames': ['Drug: Zanzalintinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Matched Healthy Control', 'description': 'Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.', 'interventionNames': ['Drug: Zanzalintinib']}], 'interventions': [{'name': 'Zanzalintinib', 'type': 'DRUG', 'otherNames': ['XL092'], 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Matched Healthy Control', 'Moderate HI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #1', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #2', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Exelixis Clinical Trials', 'role': 'CONTACT', 'email': 'druginfo@exelixis.com', 'phone': '1-888-EXELIXIS (888-393-5494)'}, {'name': 'Backup or International', 'role': 'CONTACT', 'phone': '650-837-7400'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Exelixis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exelixis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}