This study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments"). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines. The aim of the study is to see if aspirin alone or the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Oral administration
Administered intravenous (IV)
Administered IV
Oral administration
Fortrea Clinical Development
Leeds, United Kingdom
Change in fecal hemoglobin content (FHC)
Time frame: Baseline and up to day 22
Incidence of treatment-emergent adverse events (TEAE)
Time frame: Up to day 100
Severity of TEAE
Time frame: Up to day 100
Incidence of major bleeding
Time frame: Up to day 100
Incidence of clinically relevant non-major (CRNM) bleeding
Time frame: Up to day 100
Concentrations of REGN9933
Time frame: Up to day 29
Concentrations of REGN7508
Time frame: Up to day 29
Change in activated partial thromboplastin time (aPTT)
Time frame: Baseline and up day 29
Change in prothrombin time (PT)
Time frame: Baseline and up day 29
Incidence of Anti-drug antibody (ADA) to REGN9933
Time frame: Up to day 29
Titer of ADA to REGN9933
Time frame: Up to day 29
Incidence of ADA to REGN7508
Time frame: Up to day 29
Titer of ADA to REGN7508
Time frame: Up to day 29
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