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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01493869
First received: October 11, 2011
Last updated: September 19, 2014
Last verified: September 2014

October 11, 2011
September 19, 2014
September 2011
May 2014   (final data collection date for 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01493869 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Healthy
  • Hepatic Impairment
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 1
    Subjects with normal hepatic function: healthy normal adult subjects
    Intervention: Drug: cabozantinib
  • Experimental: Group 2
    Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
    Intervention: Drug: cabozantinib
  • Experimental: Group 3
    Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
    Intervention: Drug: cabozantinib
  • Experimental: Group 4
    Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
    Intervention: Drug: cabozantinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01493869
XL184-003
No
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP