- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493869
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
September 19, 2014 updated by: Exelixis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- McGuire VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Subjects with normal hepatic function: healthy normal adult subjects
|
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Names:
|
Experimental: Group 2
Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
|
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Names:
|
Experimental: Group 3
Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
|
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Names:
|
Experimental: Group 4
Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
|
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (Estimate)
December 16, 2011
Study Record Updates
Last Update Posted (Estimate)
September 22, 2014
Last Update Submitted That Met QC Criteria
September 19, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XL184-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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