Prediction of venlafaxine exposure through breastfeeding

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pharmacokinetic lactation study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VENLAFAXINE

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  The objective of this study is, using a PopPK modelling approach, to characterize the pharmacokinetics of venlafaxine and its active metabolite in breastfeeding women during the postpartum period.
• Data analysis plan:
  The pharmacokinetic characterisation of the lactating women population, will be achieved through PopPK approach, that is based on non-linear mixed effect modelling techniques. These analyses will be carried out using population PK/PD parameter estimation programs such as NONMEN, MONOLIX. PopPK allows estimating both fixed (i.e. invariant) population parameters and random effects (i.e. inter-individual and residual variability) by grouping all the samples collected in the study population. PopPK will then be used to define the main pharmacokinetic parameters of venlafaxine and its active metabolite along with their variability in milk, and to study the influence of co-factors on drugs disposition in the population of lactating mothers. This approach will combine drug and O-demethylvenlafaxine data collected in milk, while integrating clinical, demographic and environmental aspects and quantifying variability between individuals.