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

Healthy Volunteer Clinical Trial

Official title:

A Parallel Group Study in Healthy Participants to Quantify Subclinical Gastrointestinal Blood Loss Following Administration of Aspirin Alone or Aspirin in Combination With Rivaroxaban

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546957
• Other study ID #: R0000-HV-2229
• Secondary ID: 2022-002761-15
• Status: Completed
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: April 6, 2023

Study information

• Verified date: May 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key 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

Key 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.

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteer
• Hemorrhage

Intervention

Drug:
• Aspirin
Administered orally once per day (QD)
• rivaroxaban low dose
Administered orally twice per day (BID)
• rivaroxaban high dose
Administered orally QD

Locations

Country	Name	City	State
United Kingdom	LabCorp CRU	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication	HemoQuant is a chemical laboratory test of fecal hemoglobin content.	Up to Week 4
Secondary	Number of bleeding events during the baseline period as compared to the treatment period		Up to week 4