Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
- Registration Number
- NCT01126086
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate impairment otamixaban XRP0673 Patients with moderate impairment Healthy subjects otamixaban XRP0673 Matched healthy subjects Mild impairment otamixaban XRP0673 Patients with mild hepatic impairment
- Primary Outcome Measures
Name Time Method PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z Day 1 to Day 4 Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) Screening (-28 days) up to 4 days after treatment
- Secondary Outcome Measures
Name Time Method Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG Screening (-28 days) up 8 to 11 days after treament
Trial Locations
- Locations (3)
Investigational Site Number 840001
🇺🇸Orlando, Florida, United States
Investigational Site Number 840002
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 840003
🇺🇸Miami Gardens, Florida, United States