Assessing gastrointestinal blood loss in healthy adults taking aspirin with different drugs

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)

This study is testing if new drugs combined with aspirin can reduce stomach bleeding in healthy adults compared to standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (industry)
• Locations: 1 site (Leeds)
• Trial ID: NCT06444178 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of the experimental drugs REGN9933 and REGN7508 when combined with aspirin, comparing them to standard treatments that include rivaroxaban and aspirin. The primary focus is to determine whether these combinations lead to less gastrointestinal bleeding. Additionally, the study will assess potential side effects, the pharmacokinetics of the study drugs, and the body's immune response to them. Healthy adult participants will be monitored for blood loss through fecal occult blood testing.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 with a BMI between 18.0 and 32.5 kg/m2.

Not a fit: Patients with a history of major surgery or significant trauma in the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer treatment options for patients requiring anticoagulation therapy with reduced gastrointestinal bleeding risks.

How similar studies have performed: Other studies have explored similar combinations of anticoagulants and aspirin, but the specific use of REGN9933 and REGN7508 in this context is novel.

Eligibility criteria

Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
2. 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
3. Normal aPTT, normal PT, and normal platelet counts at screening period and at the day 1 visit as defined by the local laboratory
4. Hemoglobin values within the normal range, per local laboratory, at the screening and day 1 visits
5. Negative FOBT at Baseline (visit 2) and visit 3 as defined in the protocol

Key Exclusion Criteria:

1. 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
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
3. Hospitalized for any reason within 30 days of the screening visit
4. Estimated glomerular filtrate rate (eGFR) of \<60 mL/min/1.73m2 at screening as described in the protocol.
5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
6. History of illicit drug or alcohol abuse within the last 2 years prior to the day 1 visit
7. Use of any prescription and nonprescription medications or nutritional supplements from approximately 2 weeks or 5 half-lives, as described in protocol
8. Has elective surgery planned to occur prior to end of study (EOS)

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Where this trial is running

Leeds

• Fortrea Clinical Development — Leeds, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions: Healthy Volunteers, Gastrointestinal bleeding, Fecal occult blood testing