A PET Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

2025-524564-38-00 Protocol CN0140003 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol CN0140003

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 12
Countries 1
Sites 1

Neuropsychiatric indications and potentially other conditions

Key facts

Sponsor
Bristol-Myers Squibb Services Unlimited Company
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Mental Disorders [F03], Diseases [C] - Nervous System Diseases [C10]
Decision date (initial)
2026-05-22
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-524564-38-00
WHO UTN
U1111-1331-0882

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Neuropsychiatric indications and potentially other conditions

VersionLevelCodeTermSystem organ class
21.0 LLT 10013202 Disorder central nervous system 10029205

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Address
Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
City
Dublin 15
Postcode
D15 T867
Country
Ireland

Scientific contact point

Organisation
Bristol-Myers Squibb Services Unlimited Company
Contact name
GSM-CT

Public contact point

Organisation
Bristol-Myers Squibb Services Unlimited Company
Contact name
GSM-CT

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 12 1
Rest of world 0

Investigational sites

Belgium

1 site · Authorised, recruitment pending
UZ Leuven
NA, Herestraat 49, 3000, Leuven

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-04-08 Belgium Acceptable
2026-05-22
2026-05-22