A randomised, open-label, single-centre, drug-drug-interaction trial to evaluate the impact of carboxylesterase 2 (CES2)- and CYP3A4-inhibition on the pharmacokinetics of buloxibutid in healthy volunteers

2026-526135-18-00 Protocol VP-C21-016 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 12 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol VP-C21-016

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 24
Countries 1
Sites 1

Idiopathic pulmonary fibrosis

Key facts

Sponsor
Vicore Pharma AB
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
12 May 2026 → ongoing
Decision date (initial)
2026-04-28
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Idiopathic pulmonary fibrosis

VersionLevelCodeTermSystem organ class
21.1 PT 10021240 Idiopathic pulmonary fibrosis 100000004855

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vicore Pharma AB

Sponsor organisation
Vicore Pharma AB
Address
Kornhamnstorg 53
City
Stockholm
Postcode
111 27
Country
Sweden

Scientific contact point

Organisation
Vicore Pharma AB
Contact name
Global Medical Manager

Public contact point

Organisation
Vicore Pharma AB
Contact name
Global Medical Manager

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ongoing, recruiting 24 1
Rest of world 0

Investigational sites

Sweden

1 site · Ongoing, recruiting
CTC Clinical Trial Consultants AB
CTC Clinical Trial Consultants AB, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2026-05-12 2026-05-12

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-27 Sweden Acceptable
2026-04-28
2026-04-28