INTEGRATION OF PHARMACOCINETIC AND NEUROMETABOLIC DATA WITH FUNCTIONAL MRI FOR DETECTION AND QUANTIFICATION OF THE CENTRAL EFFECTS OF PARACETAMOL (IMAntalgique)

Start 12 Sep 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol 100 073

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 48

Countries 1

Sites 1

healthy volunteer

Key facts

Sponsor: Commissariat à l’Energie Atomique et aux Energies Alternatives
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration: 12 Sep 2025 → ongoing
Decision date (initial): 2024-11-05
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

healthy volunteer

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Commissariat à l’Energie Atomique et aux Energies Alternatives

Sponsor organisation: Commissariat à l’Energie Atomique et aux Energies Alternatives
Address: 25 rue Leblanc 75015 Paris
City: PARIS
Country: France

Scientific contact point

Organisation: Commissariat à l’Energie Atomique et aux Energies Alternatives
Contact name: Nicolas Tournier

Public contact point

Organisation: Commissariat à l’Energie Atomique et aux Energies Alternatives
Contact name: Nicolas Tournier

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	48	1
Rest of world	—	0	—

Investigational sites

France

1 site · Ongoing, recruiting

Service Hospitalier Frédéric Joliot - Commissariat à Energie Atomique

service hospitalier Frédéric Joliot, 4, place du Général Leclerc, ORSAY

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
France	2025-09-12		2025-09-12

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-07-29	France	Acceptable 2024-10-24	2024-11-05

Integration of Pharmacocinetic and Neurometabolic Data with Functional MRI for Detection and Quantification of the Central Effects of Paracetamol (IMAntalgique)