A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/1/2014 |
| Start Date: | May 2012 |
| End Date: | September 2013 |
| Contact: | Monette Cotreau, PhD |
| Email: | mcotreau@aveooncology.com |
| Phone: | 617-299-5000 |
A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics,
safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees
of hepatic impairment and normal hepatic function.
safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees
of hepatic impairment and normal hepatic function.
Inclusion Criteria:
- BMI between 18 to 38 kg/m2
- diagnosis of chronic or stable hepatic insufficiency, with a Child-Pugh
classification scores of mild, moderate or severe.
Exclusion Criteria:
- Current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval
shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural
effusion
- Currently undergoing dialysis
- Poor peripheral venous access
- Pregnancy or lactation
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