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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Neptune City, New Jersey, United States
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.
Time frame: Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22.
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.
Time frame: Days 1 - 8 and Days 11, 13, 15, 18, 21, 22.
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