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OpenTrials
Completed

NCT Number: 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

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)

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Development

Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
  • Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study treatment
  • Normal aPTT, normal PT, and normal platelet counts at screening period and at the day 1 visit as defined by the local laboratory
  • Hemoglobin values within the normal range, per local laboratory, at the screening and day 1 visits
  • Negative FOBT at Baseline (visit 2) and visit 3 as defined in the protocol

Key Exclusion Criteria:

  • History of any major surgical procedure or clinically significant physical trauma in the last 6 months, in the opinion of the investigator, that may pose a risk to the participant by study participation
  • Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
  • Hospitalized for any reason within 30 days of the screening visit
  • Estimated glomerular filtrate rate (eGFR) of <60 mL/min/1.73m2 at screening as described in the protocol.
  • Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
  • History of illicit drug or alcohol abuse within the last 2 years prior to the day 1 visit
  • Use of any prescription and nonprescription medications or nutritional supplements from approximately 2 weeks or 5 half-lives, as described in protocol
  • Has elective surgery planned to occur prior to end of study (EOS)

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Treatment and study plan

Aspirin

Drug

Oral administration

REGN9933

Drug

Administered intravenous (IV)

REGN7508

Drug

Administered IV

Rivaroxaban

Drug

Oral administration

Primary outcomes

  1. Change in fecal hemoglobin content (FHC)

    Time frame: Baseline and up to day 22

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (TEAE)

    Time frame: Up to day 100

  2. Severity of TEAE

    Time frame: Up to day 100

  3. Incidence of major bleeding

    Time frame: Up to day 100

  4. Incidence of clinically relevant non-major (CRNM) bleeding

    Time frame: Up to day 100

  5. Concentrations of REGN9933

    Time frame: Up to day 29

  6. Concentrations of REGN7508

    Time frame: Up to day 29

  7. Change in activated partial thromboplastin time (aPTT)

    Time frame: Baseline and up day 29

  8. Change in prothrombin time (PT)

    Time frame: Baseline and up day 29

  9. Incidence of Anti-drug antibody (ADA) to REGN9933

    Time frame: Up to day 29

  10. Titer of ADA to REGN9933

    Time frame: Up to day 29

  11. Incidence of ADA to REGN7508

    Time frame: Up to day 29

  12. Titer of ADA to REGN7508

    Time frame: Up to day 29

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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