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

Launched by REGENERON PHARMACEUTICALS · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different combinations of medications affect minor intestinal bleeding in healthy adults. Specifically, researchers want to see if taking aspirin alone or with new experimental drugs called REGN9933 and REGN7508 causes less bleeding compared to taking aspirin with a standard medication called rivaroxaban. Participants will be closely monitored to understand any side effects, how the body processes the study drugs, and if the body produces antibodies against them, which could affect their effectiveness.

To be eligible for the study, participants must be healthy adults aged 18 to 65, with a body mass index within a certain range and normal blood test results. They should not have had major surgeries, significant health issues, or certain medication use recently. Participants can expect regular check-ups and tests throughout the trial to ensure their safety and gather important information about the medications being studied.

Gender

ALL

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

Trial Officials