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

NCT01493869 | Completed Phase 1

• 1 other identifier: XL184-003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Hepatic Impairment

Keywords

Normal healthy adult subjects; Adult subjects with hepatic impairment

Outcome Measures

Primary Outcomes (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

  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

Secondary Outcomes (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

  Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22

Study Arms (4)

Group 1

EXPERIMENTAL

Subjects with normal hepatic function: healthy normal adult subjects

Drug: cabozantinib

Group 2

EXPERIMENTAL

Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).

Drug: cabozantinib

Group 3

EXPERIMENTAL

Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).

Drug: cabozantinib

Group 4

EXPERIMENTAL

Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).

Drug: cabozantinib

Interventions

cabozantinib DRUG

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

Also known as: XL184

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Exelixis: lead

Study Sites (1)

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Interventions

cabozantinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: December 16, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)