A Phase 1 open-label positron emission tomography TRIAL to assess changes in liver uptake of [68Ga]Ga-FAPI-46 following oral administration of single doses of AZD2389 to patients with advanced liver fibrosis (PECHORA)

Start 26 May 2025 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 2 sites · Protocol D7930C00003

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruitment ended

Participants planned 12

Countries 1

Sites 2

advanced liver fibrosis

Key facts

Sponsor: AstraZeneca AB
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trial duration: 26 May 2025 → ongoing
Decision date (initial): 2025-02-12
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

advanced liver fibrosis

Version	Level	Code	Term	System organ class
20.0	PT	10019668	Hepatic fibrosis	100000004871

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: Clinical Study Information Centre

Public contact point

Organisation: AstraZeneca AB
Contact name: Clinical Study Information Centre

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ongoing, recruitment ended	12	2
Rest of world	—	0	—

Investigational sites

Sweden

2 sites · Ongoing, recruitment ended

CTC Clinical Trial Consultants AB

CTC, Karolinska Vagen 22, 171 64, Solna

Karolinska University Hospital

Tema Cancer, Medicinsk Enhet Övre Buk, Halsovagen, Flemingsberg, Huddinge

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
Sweden	2025-05-26		2025-05-26	2026-05-13

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-21	Sweden	Acceptable 2025-02-12	2025-02-12
2	SUBSTANTIAL MODIFICATION	SM-1	2025-02-19	Sweden	Acceptable 2025-03-21	2025-03-26
3	SUBSTANTIAL MODIFICATION	SM-3	2025-09-11	Sweden	Acceptable 2025-10-15	2025-10-17
4	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-01-14	Sweden	Acceptable 2025-10-15	2026-01-14