Molecular Basis of Altered Drug Metabolism During Pregnancy

Withdrawn

• Conditions: Pregnancy

• Registration Number: NCT03654378
• Lead Sponsor: Northwestern University

Brief 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).

Detailed Description

The purpose of this research is to understand changes in a woman's body during pregnancy, specifically how the body processes medication during pregnancy.

The investigators know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women's body, processes such as the rate of drug metabolism can change over the course of the three trimesters.

Drug metabolism is sometimes controlled by certain genes in the body. This study will be examining the up-regulation, or "speeding up" of a certain gene called CYP3A4, a gene that helps the body process Quetiapine.

The primary goal of this research is to understand how drug metabolism changes across pregnancy. The secondary goal for this research is to define how enzymes in the liver act to up-regulate CYP3A4 during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.

The results of this study are expected to have a positive impact, as they will lay a foundation for the design of individualized drug therapy during pregnancy. This foundation will minimize the risk of over- and under-dosing pregnant women.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-45 years
• Pregnant, prior to 16 weeks gestation
• No chronic diseases or chronically administered medication
• Singleton or multiple gestation
• Subject may take aspirin, folate/multivitamins and other approved concomitant medications
• Taking Quetiapine for any clinical indication during pregnancy and postpartum
• Has made decision for Quetiapine treatment with prescriber prior to study entry

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Exclusion Criteria

• Chronic use of prescription or over the counter durgs during pregnancy with the exceptions listed under inclusions
• Substance dependence in the last 6 months
• Suicidal ideation with intent or suicide attempt in the last 6 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in concentration-to-dose ratio of Quetiapine in plasma	Between 12-15 weeks, 22-25 weeks, 32-35 weeks and 12-15 months postpartum.

Secondary Outcome Measures

Name	Time	Method
Change in thyroid hormone levels in plasma	Between 12-15 weeks, 22-25 weeks, 32-35 weeks and 12-15 months postpartum.

Trial Locations

Locations (1)

Northwestern University Asher Center for the Study and Treatment of Depressive Disorders; 🇺🇸 Chicago, Illinois, United States