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

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ClinicalTrials.gov Identifier: NCT02438631
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
Janssen Pharmaceuticals
Merck Sharp & Dohme Corp.
PENTA Foundation
Top sector Life Sciences & Health
Information provided by (Responsible Party):
Radboud University

Brief 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.

Ultimately, these 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).


Condition or disease
Pregnancy

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Placental Passage and Disposition of Drugs: A Physiology-based Approach
Actual Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. placental transfer [ Time Frame: at delivery ]
    1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs


Biospecimen Retention:   Samples With DNA
Placental tissue is retained, limited sample. DNA will not be analysed.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

Inclusion Criteria:

  • Female
  • Age > 18
  • Signed informed consent

Exclusion Criteria:

  • Retained placenta
  • HIV infected
  • Known hepatitis C infection
  • Multiple pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438631


Contacts
Contact: DM Burger david.burger@radboudumc.nl

Locations
Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands
Contact: David M Burger, PharmD PhD    ++31 24 3616405    d.burger@akf.umcn.nl   
Principal Investigator: David M Burger, PharmD PhD         
Sponsors and Collaborators
Radboud University
Janssen Pharmaceuticals
Merck Sharp & Dohme Corp.
PENTA Foundation
Top sector Life Sciences & Health
Investigators
Principal Investigator: D Burger Radboud University

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02438631     History of Changes
Other Study ID Numbers: PIANO
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Radboud University:
placenta
placental passage