Study identification

PURI

https://redirect.ema.europa.eu/resource/49090

EU PAS number

EUPAS49089

Study ID

49090

Official title and acronym

Endogenous formation of nitrosamines from drug substance (GITox)

DARWIN EU® study

No

Study countries

Germany

Study description

Endogenous formation of N-nitrosamines from drug substance. the aim of the study is to investigate the impact of physiological conditions on the formation of nitrosamines from secondary amines adjacent to various alkyl or aromatic moieties. Main topics: 1) Cultivate relevant APIs with representative microbiomal strains like Helicobacter pylori, E. coli and artificial intestinal flora under primarily anaerobic conditions to mimic conditions in the large and small intestine. 2) Investigate the impact of nitrite/nitrate concentrations and the pH-value on NA formation. 3) Investigate kinetics of NA-formation for those APIs that show biotransformation. 4) Investigate the potential of selected microbiome strains to reduce NO2- to NH4+ and thus contribute to detoxification process.

Study status

Planned
Research institutions and networks

Institutions

BfArM Berlin, University of Bonn Bonn

Contact details

Sylvia Escher

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

BfArM, ITEM/Uni Bonn
Study protocol
Initial protocol

220916 Study plan D2_revision for upload

English (1.72 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable