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

Primary Purpose

Healthy, Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cabozantinib

About this trial

This is an interventional treatment trial for Healthy focused on measuring Normal healthy adult subjects, Adult subjects with hepatic impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Subjects with normal hepatic function: healthy normal adult subjects

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

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

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

Outcomes

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

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

Full Information

NCT ID

NCT01493869

First Posted

October 11, 2011

Last Updated

September 19, 2014

Sponsor

Exelixis

1. Study Identification

Unique Protocol Identification Number

NCT01493869

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exelixis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Hepatic Impairment

Keywords

Normal healthy adult subjects, Adult subjects with hepatic impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Subjects with normal hepatic function: healthy normal adult subjects

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Experimental

Arm Description

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

Arm Title

Group 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

cabozantinib

Other Intervention Name(s)

XL184

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

McGuire VA Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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