drugset / Trial / NCT04819906
Effect of Estetrol Monohydrate (E4) on QTc Interval
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is: * to evaluate if E4 has any effect on how the heart beats when a single dose is given at two different dose levels; * to determine the ability to detect small changes in how the heart beats using a positive control: moxifloxacin, a quinolone antibiotic approved by the FDA as a positive control in thorough QT (TQT) studies; * to assess the safety and tolerability of a single dose of E4 administered at two different dose levels; * to measure the amount of study drug in the blood stream and how long it takes for the body to eliminate it (Pharmacokinetics) after administration.
Timeline
- Start
- 2021-03-09
- Primary completion
- 2021-07-14
- Completion
- 2021-07-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 20 mg | Oral |
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 100 mg | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.