Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
This study is currently recruiting participants.
Verified February 2013 by Exelixis
Sponsor:
Exelixis
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01493869
First received: October 11, 2011
Last updated: February 26, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Hepatic Impairment |
Drug: cabozantinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Exelixis:
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 [ 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.
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 [ Time Frame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 42 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Subjects with normal hepatic function: healthy normal adult subjects
|
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 2
Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
|
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 3
Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
|
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 4
Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493869
Contacts
| Contact: Exelixis Clinical Trials | 1-888-393-5494 | |
| Contact: Backup | 1-650-837-7400 |
Locations
| United States, Virginia | |
| McGuire VA Medical Center | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Principal Investigator: Douglas M Heuman, MD | |
Sponsors and Collaborators
Exelixis
More Information
No publications provided
| Responsible Party: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT01493869 History of Changes |
| Other Study ID Numbers: | XL184-003 |
| Study First Received: | October 11, 2011 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Exelixis:
|
Normal healthy adult subjects Adult subjects with hepatic impairment |
Additional relevant MeSH terms:
|
Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013