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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supratherapeutic dose of Nestorone | Experimental | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
|
| Placebo | Placebo Comparator | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
|
| Moxifloxacin | Experimental | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supratherapuetic dose of Nestorone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Nestorone (NES) administered as an IV solution on the corrected QT interval using Fridericia's formula (QTcF). | Measurement of any changes from baseline in heart rhythm using an electrocardiogram at different time points after receiving NES as an IV solution | Days 1, 2, 30, 31, 32, and 33 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George W. Creasy, MD | Population Council | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor Hospital, 3001 South Hanover Street, 7th Floor | Baltimore | Maryland | 21225 | United States |
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| Drug |
|
| Moxifloxacin | Drug |
|
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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