Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02471690 | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers | PHASE1 | COMPLETED | 56 | — | — | Jul 1, 2015 | Apr 1, 2016 | Dec 19, 2023 | 1 | United States |
A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
| Arm | Type | Description |
|---|---|---|
| Oritavancin | ACTIVE_COMPARATOR | IV -Single Dose - 1200 mg Oritavancin |
| Placebo | PLACEBO_COMPARATOR | 250 mL Dextrose 5% in Water |
| Name | Type | Description |
|---|---|---|
| Oritavancin | DRUG | IV - Single dose 1200 mg Oritavancin |
| Dextrose | DRUG | D5W 5% in Water |
Inclusion Criteria: 1. Able to provide written informed consent before initiation of any study related procedures. 2. Healthy male or female between the ages of 18 and 65 years, inclusive. 3. Body mass index (BMI) \< 45 kg/m\^2. 4. Subject is in good health based on medical history and physical exa...