A study investigating the effect of curcumin on the absorption and elimination of IMU 838, a new compound that may potentially be used in the treatment of multiple sclerosis, and the effect of IMU 838 on the absorption and elimination of rosuvastatin.

2025-523791-24-00 Protocol P1-IMU-838-DDI-BCRP Human pharmacology (Phase I) - Other Ended

Start 8 Jan 2026 · End 8 Apr 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol P1-IMU-838-DDI-BCRP

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 28
Countries 1
Sites 1

Multiple sclerosis

Key facts

Sponsor
Immunic AG
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
8 Jan 2026 → 8 Apr 2026
Decision date (initial)
2025-12-17
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

Multiple sclerosis

VersionLevelCodeTermSystem organ class
20.1 PT 10028245 Multiple sclerosis 100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immunic AG

Sponsor organisation
Immunic AG
Address
Lochhamer Schlag 21, Lochham Lochham
City
Graefelfing
Postcode
82166
Country
Germany

Scientific contact point

Organisation
Immunic AG
Contact name
Andreas Muehler

Public contact point

Organisation
Immunic AG
Contact name
Andreas Muehler

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 28 1
Rest of world 0

Investigational sites

Netherlands

1 site · Ended
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2026-01-08 2026-04-08 2026-01-15 2026-02-18

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-11-07 Netherlands Acceptable
2025-12-16
2025-12-17
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-04-13 Netherlands Acceptable
2025-12-16
2026-04-13