A study to learn about how different drugs interact with each drug in a new 7-drug mixture as they move into, through, and out of the body in healthy men

2023-504870-39-00 Protocol 22387 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol 22387

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 48
Countries 1
Sites 1

drug-drug interactions (DDI)

Key facts

Sponsor
Bayer AG
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male
Therapeutic area
Not possible to specify
Decision date (initial)
2023-10-23
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

drug-drug interactions (DDI)

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

71 Total trials 15 Recruiting 52 Ended
Commercial
Sponsor organisation
Bayer AG
City
Leverkusen
Postcode
51368
Country
Germany

Scientific contact point

Organisation
Bayer AG
Contact name
Therapeutic Area Head

Public contact point

Organisation
Bayer AG
Contact name
Therapeutic Area Head

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Authorised, recruitment pending 48 1
Rest of world — 0 —

Investigational sites

Germany

1 site · Authorised, recruitment pending
Nuvisan GmbH
Clinical Services, Wegenerstrasse 13, Ludwigsfeld, Neu-Ulm

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-08 Germany Acceptable
2023-10-16
 2023-10-23