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

NCT07312851 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

  • Healthy Participants

Interventions

DRUG

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.

DRUG

Rivaroxaban

Rivaroxaban will be administered as an oral tablet.

DRUG

Apixaban

Apixaban will be administered as an oral tablet.

DRUG

Enoxaparin

Enoxaparin will be administered as a subcutaneous injection.

OTHER

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2026-06-19
Completion
2026-06-19

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07312851 on ClinicalTrials.gov