Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07312851

A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants

Led by AstraZeneca · Updated on 2026-04-24

186

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to characterize andexanet posology and interaction between andexanet and enoxaparin post infusion in healthy participants.

CONDITIONS

Official Title

A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants must have a negative pregnancy test at screening.
  • Females of childbearing potential must not be breastfeeding and agree to use effective contraception if sexually active.
  • Sexually active fertile males must use study-approved contraception methods.
  • Body Mass Index (BMI) must be between 18.5 and 30.0 kg/m2 and weight at least 60 kg.
  • Agree to avoid alcohol, smoking, and drug abuse during the residential study period.
  • Be in good health and agree to maintain any needed dietary or nutritional supplements.
Not Eligible

You will not qualify if you...

  • History of any significant disease or disorder that could risk participant safety or affect study results.
  • History or presence of gastrointestinal, liver, or kidney disease affecting drug metabolism.
  • History of bleeding disorders or active bleeding risks.
  • History of asthma, chronic obstructive pulmonary disease, or use of inhaled medications.
  • Family history or risk factors for blood clotting disorders.
  • Past or current thrombosis or increased risk of thrombotic conditions.
  • Conditions impairing drug absorption, metabolism, or excretion.
  • Contraindications to anticoagulation or treatment with apixaban, rivaroxaban, or enoxaparin.
  • Recent significant illness or medical procedures within 4 weeks prior to study.
  • Abnormal laboratory results in chemistry, hematology, coagulation, or urinalysis.
  • Positive tests for active hepatitis B, hepatitis C, or HIV infections.
  • History of severe allergies or hypersensitivity to study drugs or similar compounds.
  • Use of certain medications including antiplatelets, NSAIDs, hormonal therapies, or new chemical entities within specified timeframes prior to study.
  • Previous receipt of andexanet.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Research Site

Berlin, Germany, 14050

Actively Recruiting

2

Research Site

Harrow, United Kingdom, HA1 3UJ

Actively Recruiting

Loading map...

Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

14

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants | DecenTrialz