An open, single arm, single-center, Phase 1 trial investigating the effect of 7-days-repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants

Start 11 Nov 2025 · End 22 Dec 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol CX842B2111

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 12

Countries 1

Sites 1

Helicobacter pylori infection, GERD

Key facts

Sponsor: Cinclus Pharma Holding AB (publ)
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trial duration: 11 Nov 2025 → 22 Dec 2025
Decision date (initial): 2025-01-21
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

Helicobacter pylori infection, GERD

Version	Level	Code	Term	System organ class
21.0	LLT	10019377	Helicobacter pylori infection	10021881
20.1	LLT	10018203	GERD	10017947

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cinclus Pharma Holding AB (publ)

Sponsor organisation: Cinclus Pharma Holding AB (publ)
Address: Kungsbron 1 Plan 3 Trappa G
City: Stockholm
Postcode: 111 22
Country: Sweden

Scientific contact point

Organisation: Cinclus Pharma Holding AB (publ)
Contact name: Gunilla Huledal

Public contact point

Organisation: Cinclus Pharma Holding AB (publ)
Contact name: Kajsa Larsson

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ended	12	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ended

CTC Clinical Trial Consultants AB

CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

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	2025-11-11	2025-12-22	2025-11-11	2025-11-19

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-18	Sweden	Acceptable 2025-01-15	2025-01-21
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-11	Sweden	Acceptable 2025-01-15	2025-11-11