A Phase 1, Single-Center, Open-Label, Fixed-Sequence, 2-Part Study to Assess the Pharmacokinetics of IMU-838 Administered Alone and in Combination with Multiple Doses of Gemfibrozil as CYP2C8 Inhibitor, or Rifampicin as CYP2C8 Inducer, in Healthy Subjects

Start 15 Aug 2025 · End 25 Feb 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol P1-IMU838–DDI-CYP2C8

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 24

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: 15 Aug 2025 → 25 Feb 2026
Decision date (initial): 2025-07-10
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

Version	Level	Code	Term	System 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

Country	MS status	Planned subjects	Sites
Netherlands	Ended	24	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 start	Trial end	Recruitment start	Recruitment end	Early termination
Netherlands	2025-08-15	2026-02-25	2025-08-15	2026-01-14

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-02	Netherlands	Acceptable 2025-07-09	2025-07-10
2	SUBSTANTIAL MODIFICATION	SM-1	2025-10-10	Netherlands	Acceptable 2025-10-22	2025-10-22
3	SUBSTANTIAL MODIFICATION	SM-2	2025-11-04	Netherlands	Acceptable	2025-11-10