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

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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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cabozantinib

Drug

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

Other names: XL184

Primary outcomes

Pharmacokinetics

Time frame: 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 outcomes

Safety and Tolerability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Jan 7, 2013
Registry last updated: Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed