Molecular Basis of Altered Drug Metabolism During Pregnancy

ClinicalTrials.gov ID: NCT03654378

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Official title

Defining Factors Responsible for Temporal Changes in CYP3A4-Mediated Drug Metabolism During Pregnancy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT03654378
Recruitment status: Withdrawn
Study type: Observational
Phase: Not listed
Lead sponsor: Northwestern University; Other
Enrollment: Not listed

Conditions and interventions

Conditions

Pregnancy

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 1, 2018 (Actual)
Primary completion: Jun 30, 2022 (Estimated)
Completion: Jun 30, 2023 (Estimated)
Last update posted: Sep 28, 2022

2018 – 2023

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders	Chicago	Illinois	60611	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03654378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 28, 2022 · Synced Nov 15, 2026