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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Exelixis
Study ID
NCT01493869
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2011
Status verified
Sep 2014
Primary completion
May 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 [ Time Frame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 ]

Locations (1)

FacilityCityStateZIPSite coordinators
McGuire VA Medical CenterRichmondVirginia23249-

Find similar trials in Richmond, VA

By research site
McGuire VA Medical Center· Richmond, VA

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