Actively Recruiting
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
Eligibility Criteria
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.
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
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Trial Site Locations
Total: 2 locations
1
Research Site
Berlin, Germany, 14050
Actively Recruiting
2
Research Site
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
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
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