A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enox… (NCT07312851) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
Germany, United Kingdom179 participantsStarted 2026-01-19
Plain-language summary
The purpose of this study is to characterize andexanet posology and interaction between andexanet and enoxaparin post infusion in healthy participants.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 k…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anti-Factor (F) Xa activity
Timeframe: Day 1 post dose
2
Change from baseline in anti-FXa activity
Timeframe: Day 1 post dose
3
Thrombin generation potential
Timeframe: Day 1 post dose
4
Change from pre-direct oral anticoagulants (DOAC) in thrombin generation potential
Timeframe: Day 1 post dose
5
Change from baseline in thrombin generation potential
Timeframe: Day 1 post dose
6
Time to onset of coagulation
Timeframe: Day 1 post dose
7
Change from pre-DOAC in time to onset of coagulation
Timeframe: Day 1 post dose
8
Change from baseline in time to onset of coagulation