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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493869
• Other study ID #: XL184-003
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2011
• Last updated: September 19, 2014
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22	No
Secondary	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		Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22	Yes