Study to Investigate Andexanet and the Interaction Between Andexanet and Subsequent Enoxaparin
Research type
Research Study
Full title
A Phase I, Randomized, Single-blind, Placebo-controlled Study to further Characterize Andexanet Posology and Assess the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
IRAS ID
1012962
Contact name
Maria Fernandez
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The trial is a multi-centre, randomised, single blind, Placebo-controlled Phase I clinical trial in up to 148 healthy males and females between the ages of 18-55 years, with a body weight of at least 60 kg, and a body mass index of 18.5-30 kg/m2.
The Sponsor is investigating a compound called andexanet alfa, which is a drug that has received approval (trade name Ondexxya®) to treat life-threatening bleeding that may occur after the administration of certain anticoagulants (blood-thinners). In this clinical trial, different dosages of andexanet and administration forms (infusion as slow continuous infusion vs. bolus as a single quick administration) will be tested in connection with the administration of anticoagulant medications (blood thinners).
The main purpose of the clinical trial is to further understand how various blood clotting values change when the currently approved dose of andexanet is given; a lower dose of andexanet is given and different treatment regimens are applied.
The clinical trial will also confirm how safe the trial medicine is and how well it is tolerated (how well the body gets used to the trial medicine) after dosing, by regularly examining vital signs (blood pressure, pulse, body temperature, oxygen saturation, and respiratory rate) and cardiac function (ECG), conducting physical examinations, and inquiring about side effects. Blood and urine samples, and stool sample (stool sample will only be taken at the Screening Visit) will also be taken to determine safety parameters.
The trial will comprise of a Screening period of 28 days, an in-house treatment period of 7 nights from Day -4 to Day 4, x1 Out-clinic Visits on Day 5 and a Follow up Visit on Day 30.This a not a first-in-human trial, which means that this medicine has been given to humans before. The trial will take place at 2 study sites in 2 countries.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0320
Date of REC Opinion
17 Dec 2025
REC opinion
Further Information Favourable Opinion