Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants

NCT ID: NCT05546957

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2023-04-06

Brief Summary

The primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical GI blood loss as determined by the HemoQuant assay.

The secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Arm 1: Aspirin QD

Randomized 1:1:1

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Administered orally once per day (QD)

Arm 2: Aspirin QD + rivaroxaban BID

Randomized 1:1:1

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Administered orally once per day (QD)

rivaroxaban low dose

Intervention Type: DRUG

Administered orally twice per day (BID)

Arm 3: Aspirin QD + rivaroxaban QD

Randomized 1:1:1

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Administered orally once per day (QD)

rivaroxaban high dose

Intervention Type: DRUG

Administered orally QD

Interventions

Aspirin

Administered orally once per day (QD)

Intervention Type: DRUG

rivaroxaban low dose

Administered orally twice per day (BID)

Intervention Type: DRUG

rivaroxaban high dose

Administered orally QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive

2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed during screening

3. Is in good health based on laboratory safety testing obtained at the screening visit

4. Willing and able to abstain from alcohol use for the duration of the study

Exclusion Criteria

1. History of anemia, abnormal bleeding (including vaginal bleeding or excessive menstrual periods), previous diagnosis of bleeding diathesis, or blood clots as defined in the protocol

2. History, in the last year, of any bleeding GI lesions such as peptic ulcer, hemorrhoids or anal fissure, or a positive fecal occult blood test performed either during screening or on Day 1

3. Presence of irregular stool patterns, constipation, or frequent diarrhea that, in the opinion of the investigator, may interfere with stool collections required by the protocol

4. Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.

5. Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal

6. PT and aPTT values above the upper limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal

7. Platelet count below the lower limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal

8. History of clinically significant respiratory, hepatic, renal, GI, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation.

History of any atherosclerotic cardiovascular disease

9. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

10. Has received a COVID-19 vaccination within 1 week of day 1 of the study or for which the planned COVID-19 vaccinations would not be completed 1 week prior to day 1 of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

LabCorp CRU

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2022-002761-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R0000-HV-2229

Identifier Type: -

Identifier Source: org_study_id