This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
12
UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours
Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours
Saline (placebo) Constant IV infusion for 4 hours
Clinical Pharmacology of Miami
Miami, Florida, United States
Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia
Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (Analysis of Variance; ANOVA) at the following time points: Pre-UFH, Pre-Study-Drug infusion start and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours Post-Study-Drug infusion start.
Time frame: Pre-UFH to 24 hours post-study drug administration
Mean difference over 12 hours of anti-factor Xa (IU/mL) when UFH is administered with and without Bendavia
Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (ANOVA) at the following time points: Pre-UFH, Pre-Study-Drug infusion start and 4, 8 and 12 hours Post-Study-Drug infusion start.
Time frame: Pre-UFH to 12 hours post-study drug administration
Mean difference in Bendavia Area Under the Curve(0-infinity) (AUC) when Bendavia is administered with and without UFH (historical data will be used to provide bendavia without UFH)
Time frame: 48 hours post-study-drug administration
Difference in number of adverse events when UFH is administered with and without Bendavia
Adverse events will be described by treatment group (UFH with and without Bendavia). No statistical analysis of the difference between AEs will be conducted.
Time frame: Pre-dose through Day 10
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