NCT06444178

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants

A Parallel Group Study in Healthy Participants to Quantitate Increases in Subclinical Gastrointestinal Blood Loss Following Administration of Aspirin Alone or in Combination With Rivaroxaban or Factor XI Inhibitors (REGN9933 or REGN7508)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Aspirin	Oral administration
DRUG	REGN9933	Administered intravenous (IV)
DRUG	REGN7508	Administered IV
DRUG	Rivaroxaban	Oral administration

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-04-07
• Completion: 2025-07-09
• First posted: 2024-06-05
• Last updated: 2025-07-16

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study