Status: Planned First registered on: 26/09/2022
Last updated on: 26/09/2022
1. Study identification
EU PAS Register NumberEUPAS49089
Official titleEndogenous formation of nitrosamines from drug substance
Study title acronymGITox
Study typeOther: Study on the formation of Nitrsoamines by the gastro intestinal tract using in vitro approaches
Brief description of the studyEndogenous 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableSPECIFIC CONTRACT No. 03 implementing framework contract No. EMA/2020/46/L1.02
2. Research centres and Investigator details
Coordinating study entity
Centre nameFraunhofer ITEM
Centre locationHannover, Germany
Details of (Primary) lead investigator
Title Dr
Last name Escher
First name Sylvia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3
BfArM, Berlin
University of Bonn, Bonn
Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/12/2021
Start date of data collection01/01/2022
Start date of data analysis01/09/2022
Date of interim report, if expected31/03/2023
Date of final study report30/06/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyBfArM35
Research councilsITEM/Uni Bonn65
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Escher
First name Sylvia
Address line 1Feodor-Lynen Str. 1
Address line 2 
Address line 3 
CityHannover 
Postcode30625 
CountryGermany
Phone number (incl. country code)00491622916659 
Alternative phone number 
Fax number (incl. country code) 
Email address sylvia.escher@item.fraunhofer.de
Public Enquiries
Title Dr 
Last name Escher 
First name Sylvia 
Address line 1Feodor-Lynen Str. 1 
Address line 2 
Address line 3 
CityHannover 
Postcode30625 
CountryGermany 
Phone number (incl. country code)00491622916659 
Alternative phone number 
Fax number (incl. country code) 
Email address sylvia.escher@item.fraunhofer.de 
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