Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444178
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban or Aspirin Plus REGN9933 or Aspirin Plus REGN7508 in Healthy Adult Participants
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None