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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05546957
Collaborator
(none)
60
1
3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin
  • Drug: rivaroxaban low dose
  • Drug: rivaroxaban high dose
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Parallel Group Study in Healthy Participants to Quantify Subclinical Gastrointestinal Blood Loss Following Challenge With Aspirin Alone or Aspirin in Combination With Rivaroxaban
Anticipated Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Apr 28, 2023
Anticipated Study Completion Date :
May 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Aspirin QD

Randomized 1:1:1

Drug: Aspirin
Administered orally once per day (QD)

Experimental: Arm 2: Aspirin QD + rivaroxaban BID

Randomized 1:1:1

Drug: Aspirin
Administered orally once per day (QD)

Drug: rivaroxaban low dose
Administered orally twice per day (BID)

Experimental: Arm 3: Aspirin QD + rivaroxaban QD

Randomized 1:1:1

Drug: Aspirin
Administered orally once per day (QD)

Drug: rivaroxaban high dose
Administered orally QD

Outcome Measures

Primary Outcome Measures

  1. Change in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to challenge medications [Up to Week 4]

    HemoQuant is a chemical laboratory test of fecal hemoglobin content.

Secondary Outcome Measures

  1. Number of bleeding events during the baseline period as compared to the challenge period [Up to week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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

  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 LabCorp CRU Leeds West Yorkshire United Kingdom LS2 9LH

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05546957
Other Study ID Numbers:
  • R0000-HV-2229
  • 2022-002761-15
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Regeneron Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022