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

NCT ID: NCT07312851

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-06-19

Brief Summary

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

Detailed Description

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This is a single-blind, placebo-controlled study. The study has 4 modules, which is then divided into 2 parts. Part A of the study will focus on further characterization of andexanet posology and Part B of the study will evaluate a re-institution of anticoagulation with enoxaparin.

Module 1, 2 and 4 - rivaroxaban, apixaban and enoxaparin: These modules are designed to determine the pharmacodynamic (PD) effect of andexanet by assessing its reversal effects on rivaroxaban and apixaban anticoagulation, or assessing its effects in the absence of anticoagulants, and to identify the time interval after andexanet administration at which andexanet shows no impact on enoxaparin.

Module 3 - rivaroxaban and apixaban: This Module is designed to determine the PD effect of bolus only andexanet by assessing its reversal effect on rivaroxaban and apixaban anticoagulation.

All the Modules will comprise:

* A Screening/Enrollment Period of maximum 28 days.
* An in-house stay comprising of a safety baseline lab period (Day -3 to Day -1)
* Treatment period (Day 1 to Day 2)
* Safety follow-up period (Day 3 to Day 5)
* A final Follow-up Visit within 30 days (+7 days) after the last andexanet/placebo administration.

Conditions

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Healthy Participants

Keywords

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Posology Re-anticoagulation Pharmacodynamics Life-threatening or uncontrolled bleeding Thrombotic events Factor Xa inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 Modules divided into 2 Parts
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single blind

Study Groups

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Module 1: Rivaroxaban + Andexanet (dose A)

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose A) dosing, the participants will receive an additional dose of rivaroxaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Enoxaparin

Intervention Type DRUG

Enoxaparin will be administered as a subcutaneous injection.

Module 1: Rivaroxaban + Andexanet (dose B)

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of rivaroxaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Module 1: Rivaroxaban + Andexanet (dose C)

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional dose of rivaroxaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Module 1: Rivaroxaban + Placebo

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of rivaroxaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after placebo administration.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Enoxaparin

Intervention Type DRUG

Enoxaparin will be administered as a subcutaneous injection.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Module 2: Apixaban + Andexanet (dose B)

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of apixaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Enoxaparin

Intervention Type DRUG

Enoxaparin will be administered as a subcutaneous injection.

Module 2: Apixaban + Andexanet (dose C)

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional dose of apixaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Module 2: Apixaban + Andexanet (dose D)

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose D) dosing, the participants will receive an additional dose of apixaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Module 2: Apixaban + Placebo

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of apixaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after placebo administration.

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Enoxaparin

Intervention Type DRUG

Enoxaparin will be administered as a subcutaneous injection.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Module 3: Rivaroxaban + Andexanet (Dose A)

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose A) dosing, the participants will receive an additional dose of rivaroxaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Module 3: Apixaban + Andexanet (Dose B)

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of apixaban.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Module 3: Rivaroxaban + Placebo

Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose A of andexanet) dosing, the participants will receive an additional dose of rivaroxaban.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Rivaroxaban will be administered as an oral tablet.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Module 3: Apixaban + Placebo

Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of apixaban.

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban will be administered as an oral tablet.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Module 4: Placebo + Andexanet (dose C)

Participants will receive daily dose of one placebo tablet from Day -3 to Day -1. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional placebo tablet.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Module 4: Placebo + Andexanet (dose B)

Participants will receive daily dose of one placebo tablet from Day -3 to Day -1. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional placebo tablet. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus.

Group Type EXPERIMENTAL

Andexanet alfa

Intervention Type DRUG

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Enoxaparin

Intervention Type DRUG

Enoxaparin will be administered as a subcutaneous injection.

Placebo

Intervention Type OTHER

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Interventions

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Andexanet alfa

Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given.

Intervention Type DRUG

Rivaroxaban

Rivaroxaban will be administered as an oral tablet.

Intervention Type DRUG

Apixaban

Apixaban will be administered as an oral tablet.

Intervention Type DRUG

Enoxaparin

Enoxaparin will be administered as a subcutaneous injection.

Intervention Type DRUG

Placebo

Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban.

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Parexel

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Berlin, , Germany

Site Status

Research Site

Harrow, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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2025-522513-30-00

Identifier Type: OTHER

Identifier Source: secondary_id

D9609C00001

Identifier Type: -

Identifier Source: org_study_id