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

NCT ID: NCT01493869

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

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.

Conditions

Healthy; Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Subjects with normal hepatic function: healthy normal adult subjects

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

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

Group 2

Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

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

Group 3

Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

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

Group 4

Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

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

Interventions

cabozantinib

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

Intervention Type: DRUG

Other Intervention Names

XL184

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

XL184-003

Identifier Type: -

Identifier Source: org_study_id