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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Pharmaceutical form: solution for injection Route of administration: intravenous
Investigational Site Number 840003
Miami Gardens, Florida, United States
Investigational Site Number 840001
Orlando, Florida, United States
Investigational Site Number 840002
Knoxville, Tennessee, United States
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
Time frame: Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)
Time frame: Screening (-28 days) up to 4 days after treatment
Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG
Time frame: Screening (-28 days) up 8 to 11 days after treament
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.