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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01493869
First received: October 11, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Hepatic Impairment
Drug: cabozantinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Subjects with normal hepatic function: healthy normal adult subjects
Drug: cabozantinib
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Name: XL184
Experimental: Group 2
Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
Drug: cabozantinib
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Name: XL184
Experimental: Group 3
Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
Drug: cabozantinib
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Name: XL184
Experimental: Group 4
Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
Drug: cabozantinib
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Name: XL184

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493869

Locations
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01493869     History of Changes
Other Study ID Numbers: XL184-003
Study First Received: October 11, 2011
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
Normal healthy adult subjects
Adult subjects with hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014