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The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with 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 renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2. |
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| Group 2 | Experimental | Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2. |
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| Group 3 | Experimental | Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2. |
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| Group 4 | Experimental | Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabozantinib | Drug | 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | AUC, Cmax, tmax, kel, t1/2, CL/F, V/F and fu as measure of a single oral 60 mg dose of cabozantinib in adults with impaired renal function compared with healthy subjects matched for age, gender, and body mass index (BMI). Subjects will receive a single oral 60 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 - 8 following this single dose, as well as on the mornings of Days 11, 13, 15, 18, 21, 22. | Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 60 mg dose in adult subjects with impaired renal function and in healthy adult subjects. | Days 1 - 8 and Days 11, 13, 15, 18, 21, 22. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33136 | United States | |||
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
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|
| Orlando |
| Florida |
| 32809 |
| United States |
| Neptune City | New Jersey | 07753 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |