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RECRUITING
NCT02438631

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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).

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2015-02

Completion Date

2028-12

Last Updated

2022-09-10

Healthy Volunteers

Yes

Conditions

Locations (1)

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands