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

Phase 1

Completed

• Conditions: Healthy; Hepatic Impairment
• Interventions: Drug: cabozantinib

• Registration Number: NCT01493869
• Lead Sponsor: Exelixis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-19
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	cabozantinib	Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
Group 4	cabozantinib	Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
Group 1	cabozantinib	Subjects with normal hepatic function: healthy normal adult subjects
Group 3	cabozantinib	Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States