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The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects with normal hepatic function: healthy normal adult subjects |
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| Group 2 | Experimental | Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6). |
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| Group 3 | Experimental | Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9). |
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| Group 4 | Experimental | Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabozantinib | Drug | 3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity | Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22. | Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects | Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
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