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

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ClinicalTrials.gov Identifier: NCT01493869
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Hepatic Impairment Drug: cabozantinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493869


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

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01493869     History of Changes
Other Study ID Numbers: XL184-003
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases