CLINICAL TRIALS PROFILE FOR ERAVACYCLINE DIHYDROCHLORIDE
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All Clinical Trials for Eravacycline Dihydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01265784 ↗ | Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 2 | 2011-01-01 | This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs). |
| NCT01844856 ↗ | Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 3 | 2013-08-01 | This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI). |
| NCT01941446 ↗ | A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 1 | 2013-03-01 | 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. |
| NCT01978938 ↗ | Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 3 | 2014-10-06 | This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI). |
| NCT01989949 ↗ | Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women | Completed | Department of Health and Human Services | Phase 1 | 2012-11-01 | This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434. |
| NCT01989949 ↗ | Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 1 | 2012-11-01 | This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434. |
| NCT02135276 ↗ | A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects | Completed | Tetraphase Pharmaceuticals, Inc. | Phase 1 | 2013-12-01 | This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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