A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition

2025-520763-41-00 Protocol C4541011 Human pharmacology (Phase I) - Other Ended

End 21 Jan 2026 · Status Ended · 1 EU/EEA countries · 3 sites · Protocol C4541011

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 60
Countries 1
Sites 3

Older adults at risk of malnutrition

Key facts

Sponsor
Pfizer Inc.
Participant type
Healthy volunteers
Age range
65+ years
Gender
Male and Female
Therapeutic area
Not possible to specify
Trial duration
completed 21 Jan 2026
Decision date (initial)
2025-11-19
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

Older adults at risk of malnutrition

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation
Pfizer Inc.
Address
66 Hudson Boulevard East
City
New York
Postcode
10001-2189
Country
United States

Scientific contact point

Organisation
Pfizer Inc.
Contact name
Clinical Medical Lead

Public contact point

Organisation
Pfizer Inc.
Contact name
Clinical Medical Lead

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ended 4 3
Rest of world
Japan, Canada, United States
56

Investigational sites

Spain

3 sites · Ended
Bellvitge University Hospital
Servicio Medicina Interna, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Geriatría, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario De Albacete
Geriatría, Calle Hermanos Falco 37, 02006, Albacete

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-31 Spain Acceptable with conditions
2025-11-17
2025-11-19