A Phase 1 interventional study of cabozantinib in Healthy and Hepatic Impairment, sponsored by Exelixis. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-22.
Sponsored by Exelixis · Phase 1, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Exelixis is the lead sponsor of 57 studies on the registry; 12 are open to participants now.
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Inclusion Criteria:
Subjects with normal hepatic function: healthy normal adult subjects
Drug: cabozantinib
Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
Drug: cabozantinib
Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
Drug: cabozantinib
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
Also known as: XL184
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.
Time frame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
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
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Exelixis