New study explores how to reverse common blood thinners
NCT ID NCT07312851
First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This early-stage study tests a drug called andexanet alfa, which is designed to reverse the effects of common blood thinners like rivaroxaban and apixaban. Researchers will give these blood thinners to 179 healthy volunteers, then give andexanet to see how well it works and how it interacts with another blood thinner, enoxaparin. The goal is to learn more about dosing and timing, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- andexanet alfa
- What this could lead to
- If successful, this could help doctors better understand how to reverse the effects of certain blood thinners in emergencies.
- What could go wrong
- This is a very early Phase 1 study in healthy volunteers, not patients. It only measures lab effects, not real-world outcomes, and may not translate to clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
191 people
The number who actually took part.
- Started
-
Jan 2026
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods. * Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2 (both inclusive) and weigh at least 60 kg. * Agree to abstain from alcohol consumption or smoking for the duration of the residential period, and from the use of drugs of abuse for the duration of the study. * Be in good health and agree to have any dietary or nutritional supplements, if needed. Main Exclusion Criteria: * History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study. * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * History of abnormal bleeding or bleeding disorders (eg, hemophilia, von Willebrand disease), signs or symptoms of active bleeding, or risk factors for bleeding. * History of adult asthma or chronic obstructive pulmonary disease or current regular or as needed use of inhaled medications. * Family history of or known risk factors for a hypercoagulable or thrombotic condition or thrombotic event, such as anti-phospholipid syndrome; Factor V Leiden carrier or homozygote; Protein C, S, or AT3 activity below the normal range. * Past or current medical history of thrombosis, any sign or symptom that suggests an increased risk of a systemic thrombotic condition, or recent events that may increase risk of thrombosis. * Any medical or surgical conditions which may impair drug (anticoagulant or andexanet) uptake, metabolism, or excretion. * An absolute or relative contraindication to anticoagulation or treatment with apixaban, rivaroxaban or enoxaparin. * Any clinically significant illness or medical procedure within 4 weeks of the first administration of study intervention. * Any clinically significant abnormalities in clinical chemistry, hematology, coagulation or urinalysis results * Any positive result on Screening for serum hepatitis B surface antigen (HBsAg) OR anti-hepatitis B core (HBc) antibody, indicative of active hepatitis B (ie, participants with positive anti-HBc antibody result are acceptable if anti-HBc IgM antibodies are negative), anti- hepatitis C virus (HCV) or human immunodeficiency virus (HIV). * History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, including heparin-induced thrombocytopenia, or history of hypersensitivity to drugs with a similar chemical structure or class to andexanet, apixaban, rivaroxaban, or enoxaparin or any of the vehicle ingredients. * Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, intake of \> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention or longer (\> 5 half-lives) if the medication has a long half-life. The participant has taken (by any route) one or more doses of aspirin (including baby aspirin), salicylate or subsalicylate, other antiplatelet drugs (eg, ticagrelor, clopidogrel, ticlopidine), non-steroidal anti-inflammatory drugs, fibrinolytic, or any anticoagulant within 7 days prior to Admission or is anticipated to require such drugs during the study. The participant has been receiving (by any route) hormonal contraception, postmenopausal HRT (including over-the-counter products), or testosterone during the 4 weeks prior to Admission or is anticipated to require such drugs during the study. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of Admission. * Participants who have previously received andexanet.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Berlin, 14050, Germany
-
Research Site
Harrow, HA1 3UJ, United Kingdom
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