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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate HI | Experimental | Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1. |
|
| Matched Healthy Control | Active Comparator | Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanzalintinib | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib | Predose up to 7 days postdose | |
| Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib | Predose up to 7 days postdose | |
| Time to Cmax (Tmax) of Zanzalintinib | Predose up to 7 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 30 days |
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Key Inclusion Criteria:
All Participants:
Participants with Moderate HI Only:
Healthy Control Participants Only:
Key Exclusion Criteria:
All Participants:
Participants with Moderate HI Only:
Healthy Control Participants Only:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exelixis Clinical Trials | Contact | 1-888-EXELIXIS (888-393-5494) | druginfo@exelixis.com | |
| Backup or International | Contact | 650-837-7400 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exelixis Clinical Site #1 | Recruiting | Orlando | Florida | 32809 | United States | |
| Exelixis Clinical Site #2 |
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| Recruiting |
| San Antonio |
| Texas |
| 78215 |
| United States |