Influence of Genetic Polymorphisms on Progesterone-Associated Attenuation of Drug-Induced QT Interval Lengthening
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- STATUS
- Not Recruiting
Summary
We aim to identify potential polymorphisms in genes that could influence variability in the progesterone response to drug-induced QT interval prolongation, including potential polymorphisms in genes encoding: cytochrome P (CYP) 450 3A5, which is a major contributor to progesterone metabolism;3 other CYP enzymes contributing to progesterone metabolism, including 2C19, 2C9, and 3A4;4 progesterone receptors;5 estrogen receptors; potassium current, including hERG and KCNQ1; and sodium and calcium current. In addition, we aim to perform pharmacokinetic (PK)-pharmacodynamic (PD) modeling of the relationship between serum ibutilide concentrations and QTc interval, to determine if variability in that relationship influenced the response to progesterone in individual subjects.
Description
We aim to identify potential polymorphisms in genes that could influence variability in the progesterone response to drug-induced QT interval prolongation, including potential polymorphisms in genes encoding: cytochrome P (CYP) 450 3A5, which is a major contributor to progesterone metabolism;3 other CYP enzymes contributing to progesterone metabolism, including 2C19, 2C9, and 3A4;4 progesterone receptors;5 estrogen receptors; potassium current, including hERG and KCNQ1; and sodium and calcium current. In addition, we aim to perform pharmacokinetic (PK)-pharmacodynamic (PD) modeling of the relationship between serum ibutilide concentrations and QTc interval, to determine if variability in that relationship influenced the response to progesterone in individual subjects.
Details
| Condition | healthy |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8619 |
| Last Modified on | 19 February 2024 |
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