A trial to learn how well different doses of andexanet alfa work and how they affect blood clotting throughout the body in healthy adults who have taken an FXa inhibitor

Start 12 Jan 2026 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol D9609C00001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruitment ended

Participants planned 186

Countries 1

Sites 1

Healthy Volunteers

Key facts

Sponsor: AstraZeneca AB
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 12 Jan 2026 → ongoing
Decision date (initial): 2026-01-09
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Healthy Volunteers

Version	Level	Code	Term	System organ class
26.0	LLT	10088820	Clinical trial healthy volunteer	100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation: AstraZeneca AB
Address: -
City: Sodertalje
Postcode: 151 85
Country: Sweden

Scientific contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Centre

Public contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Centre

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruitment ended	108	1
Rest of world United Kingdom	—	78	—

Investigational sites

Germany

1 site · Ongoing, recruitment ended

PAREXEL International GmbH

2601; Parexel Early Phase Unit Berlin, Klinikum Westend Haus 31, Spandauer Damm 130, Berlin

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2026-01-12		2026-01-19	2026-05-07

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-10-17	Germany	Acceptable 2026-01-08	2026-01-09