Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects

A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01493869

Enrollment

Registered

2011-12-16

Start date

2011-09-30

Completion date

2014-08-31

Last updated

2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hepatic Impairment

Keywords

Normal healthy adult subjects, Adult subjects with hepatic impairment

Brief summary

The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.

Interventions

DRUGcabozantinib

3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight must be ≥50 kg and \<130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2). * Must use acceptable forms 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. * 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

Design outcomes

Primary

Measure	Time frame	Description
AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity	Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22	Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22.

Secondary

Measure	Time frame
Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects	Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026