Actively Recruiting
Placental Passage and Disposition of Drugs: A Physiology-based Approach
Led by Radboud University Medical Center · Updated on 2022-09-10
2000
Participants Needed
1
Research Sites
721 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Placental Passage and Disposition of Drugs: A Physiology-based Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age > 18
- Signed informed consent
- More than 38 weeks pregnant
You will not qualify if you...
- Retained placenta
- HIV infected
- Known hepatitis C infection
- Multiple pregnancy
- Child with congenital birth defects
- Sectio EXIT procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Actively Recruiting
Research Team
J
J van Drongelen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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