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Molecular Basis of Altered Drug Metabolism During Pregnancy

NCT03654378 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-09-28

No results posted yet for this study

Summary

The objectives of this application are to provide mechanistic understanding of altered drug metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A drug metabolized by CYP3A4, Quetiapine, will be the drug of choice mechanism to understand the enzyme's induction. Pregnant women currently on Quetiapine will be recruited. If the women enroll, the women will participate in four pharmacokinetic (PK) studies (one per trimester, and one postpartum).

Conditions

  • Pregnancy

Sponsors & Collaborators

Principal Investigators

  • Katherine L Wisner, M.D., M.S. · Northwestern University

  • Hyunyoung Jeong, PharmD, PhD · University of Illinois at Chicago

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • United States

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 NCT03654378 on ClinicalTrials.gov