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

NCT02438631 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-09-10

No results posted yet for this study

Summary

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).

Conditions

  • Pregnancy

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • PENTA Foundation

    collaborator NETWORK

  • Top sector Life Sciences & Health

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • J van Drongelen · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438631 on ClinicalTrials.gov