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

Primary Purpose

Healthy Volunteer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspirin
rivaroxaban low dose
rivaroxaban high dose
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthy Volunteer focused on measuring No gastrointestinal (GI) disease, No risk factors for bleeding, Direct oral anticoagulant (DOAC), Fecal occult blood testing (FOBT)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 prior to randomization
  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 planned start of challenge drug regimen or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of challenge agent

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Sites / Locations

  • LabCorp CRU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1: Aspirin QD

Arm 2: Aspirin QD + rivaroxaban BID

Arm 3: Aspirin QD + rivaroxaban QD

Arm Description

Randomized 1:1:1

Randomized 1:1:1

Randomized 1:1:1

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of bleeding events during the baseline period as compared to the treatment period

Full Information

First Posted
September 15, 2022
Last Updated
May 23, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05546957
Brief Title
Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteer
Keywords
No gastrointestinal (GI) disease, No risk factors for bleeding, Direct oral anticoagulant (DOAC), Fecal occult blood testing (FOBT)

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Aspirin QD
Arm Type
Experimental
Arm Description
Randomized 1:1:1
Arm Title
Arm 2: Aspirin QD + rivaroxaban BID
Arm Type
Experimental
Arm Description
Randomized 1:1:1
Arm Title
Arm 3: Aspirin QD + rivaroxaban QD
Arm Type
Experimental
Arm Description
Randomized 1:1:1
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Administered orally once per day (QD)
Intervention Type
Drug
Intervention Name(s)
rivaroxaban low dose
Intervention Description
Administered orally twice per day (BID)
Intervention Type
Drug
Intervention Name(s)
rivaroxaban high dose
Intervention Description
Administered orally QD
Primary Outcome Measure Information:
Title
Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication
Description
HemoQuant is a chemical laboratory test of fecal hemoglobin content.
Time Frame
Up to Week 4
Secondary Outcome Measure Information:
Title
Number of bleeding events during the baseline period as compared to the treatment period
Time Frame
Up to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive 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 Is in good health based on laboratory safety testing obtained at the screening visit Willing and able to abstain from alcohol use for the duration of the study Key Exclusion Criteria: 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 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 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 Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc. Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal 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 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 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
LabCorp CRU
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9LH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/

Learn more about this trial

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

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