A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761773
• Other study ID #: XL184-017
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2013
• Last updated: September 19, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• cabozantinib
3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes