Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | May 2011 |
An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 μg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
Primary Objective:
- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of
otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate
hepatic impairment and in matched subjects with normal hepatic function.
The duration of each part of the study for one subject was 28 days of screening, 1 day of
treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after
start of infusion.
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