Back to resultsA Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Primary Purpose
Healthy, Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cabozantinib
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.
Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.
Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.
Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01761773
Brief Title
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Official Title
A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.
Intervention Type
Drug
Intervention Name(s)
cabozantinib
Other Intervention Name(s)
XL184
Intervention Description
3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
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.
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
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