Endogenous formation of nitrosamines from drug substance (GITox)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Formation of impurities in drugs

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Research study testing in vitro assays

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B03BB) Folic acid and derivatives

  Folic acid and derivatives

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  Investigate the impact of physiological conditions on the formation of nitrosamines from secondary amines adjacent to various alkyl or aromatic moieties.
• Outcomes:
  Define the conditions under which N-nitrosamines can be formed in the gastrointestinal tract and derive structure-activity relationships.
• Data analysis plan:
  Kinetics of NA formation from selected agents simulating realistic conditions in the GIT