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

Exelixis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: cabozantinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493869

XL184-003

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Group 1

Experimental group

Description:

Subjects with normal hepatic function: healthy normal adult subjects

Treatment:

Drug: cabozantinib

Group 2

Experimental group

Description:

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

Treatment:

Drug: cabozantinib

Group 3

Experimental group

Description:

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

Treatment:

Drug: cabozantinib

Group 4

Experimental group

Description:

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

Treatment:

Drug: cabozantinib