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NCT Number: NCT02438631

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

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).

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Location status: Recruiting

Location contact

Joris M van Drongelen, MD PhD

CONTACT

[email protected]

Joris van Drongelen

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. placental transfer

    Time frame: at delivery

    1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

J van Drongelen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Janssen Pharmaceuticals
  • Merck Sharp & Dohme LLC
  • PENTA Foundation
  • Top sector Life Sciences & Health

Registry information

Acronym: PIANO

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
May 8, 2015
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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