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This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through 3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4 nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a minimum of a 14 day washout between treatments.
Each of the following treatments will be evaluated on Day 1 of each period in a crossover fashion. The IV eravacycline (TP-434) and IV placebo will be double-blinded.
Subjects will be randomized to a treatment sequence according to a pre-generated treatment scheme. Subjects will receive a different treatment during each of the 3 periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-generated treatment scheme | Experimental | Treatment A: Eravacycline (TP-434) 1.5 mg/kg administered intravenously over 60 minutes and one placebo oral tablet |
|
| Pre-generated tratment scheme | Placebo Comparator | Treatment B: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes and one moxifloxacin 400 mg oral tablet |
|
| Moxifloxacin | Placebo Comparator | Treatment C: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes and one placebo oral tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eravacyline, Moxifloxacin, and placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of a therapeutic dose of an IV infusion of eravacycline (TP-434) on cardiac repolarization compared to placebo | Calculating the differences between time-matched mean change from baseline of QTcI (ΔΔQTcI = ΔQTcI[TP-434]-ΔQTcI[placebo]) in healthy male and female subjects. | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of eravacycline (TP-434) on cardiac repolarization |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick T Horn, MD, PhD | Tetraphase Pharmaceuticals, Inc | Study Director |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| 11 weeks |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |