Nifedipine Metabolism in Pregnancy
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 9/2/2018 |
| Start Date: | August 1, 2018 |
| End Date: | December 2022 |
| Contact: | Minaz K Cattan, M.D. |
| Email: | minaz.kolia@northwestern.edu |
| Phone: | 312-695-7190 |
Defining Factors Responsible for Temporal Changes in CYP3A4-Mediated Drug Metabolism During Pregnancy
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, Nifedipine, will be the drug of choice mechanism to understand
the enzyme's induction. Pregnant women currently on Nifedipine to treat high blood pressure
will be recruited. If the women enroll, the women will participate in four pharmacokinetic
(PK) studies (one per trimester, and one postpartum).
metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A
drug metabolized by CYP3A4, Nifedipine, will be the drug of choice mechanism to understand
the enzyme's induction. Pregnant women currently on Nifedipine to treat high blood pressure
will be recruited. If the women enroll, the women will participate in four pharmacokinetic
(PK) studies (one per trimester, and one postpartum).
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 Nifedipine, a drug commonly used to treat high blood pressure.
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.
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 Nifedipine, a drug commonly used to treat high blood pressure.
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.
Inclusion Criteria:
- Age 18-45 years
- Pregnant, prior to 16 weeks gestation
- Hypertension treated with oral extended-release nifedipine
- Singleton gestation
Exclusion Criteria:
- Current use of other therapies for hypertension
- Chronic use of prescription drugs that are substrates or inhibitors of CYP3A4 enzyme
activity
We found this trial at
1
site
446 East Ontario Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Katherine L Wisner, M.D., M.S.
Phone: 312-695-7190
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