Healthy, Renal Impairment
Conditions
Brief summary
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.
Interventions
DRUGcabozantinib
3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.
Sponsors
Exelixis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight must be ≥ 50 kg and \< 130 kg with a BMI ≤ 38.0 (kg/m2). * Must use acceptable form of birth control during the course of the study and for 3 months following the single dose of study drug. * Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in. * Negative test for HIV; hepatitis A, B, and C. * Must have adequate vital sign reads at screening and check-in. * Must be able to comply with dietary and fluid restrictions required for the study.
Exclusion criteria
* History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug. * Recent clinical evidence of pancreatic injury. * Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes. * Previous diagnosis of malignancy. * Unwilling to forgo use of any over-the-counter or non-prescription preparations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Days 1 - 8 and Days 11, 13, 15, 18, 21, 22. | 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. |
Countries
United States
Outcome results
None listed