Placental Passage and Disposition of Drugs: A Physiology-based Approach

Overview

The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network. PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 2028

Clinical Trial Outcome Measures

Primary Measures

  • placental transfer
    • Time Frame: at delivery
    • 1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs
  • histological profiling
    • Time Frame: at delivery
    • Histological and protein profiling experiments will be conducted to investigate factors that may influence the placental passage and disposition of drugs (e.g. the abundance, localization and inter-individual variation of expression of enzymes and transporters).
  • in vitro experiments
    • Time Frame: at delivery
    • Furthermore, in vitro experiments will be conducted to estimate the pharmacodynamic effects of drugs on the placental barrier function itself (e.g. whether exposure to drugs can induce/reduce the expression of enzymes and transporters, as has been reported for several organs, such as the liver, intestine and kidney).

Participating in This Clinical Trial

Inclusion Criteria

  • Female – Age > 18 – Signed informed consent – >38 weeks pregnant Exclusion Criteria:

  • Retained placenta – HIV infected – Known hepatitis C infection – Multiple pregnancy – Congenital birth defects child – Sectio EXIT procedure

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Collaborator
    • Janssen Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • J van Drongelen, Principal Investigator, Radboud University Medical Center
  • Overall Contact(s)
    • J van Drongelen, joris.vandrongelen@Radboudumc.nl

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