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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03873987 | Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients | PHASE1 | COMPLETED | 102 | — | — | Jul 16, 2019 | Sep 4, 2019 | Apr 13, 2021 | 4 | United States |
Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)
| Arm | Type | Description |
|---|---|---|
| Current Formulation of Oritavancin | ACTIVE_COMPARATOR | Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. |
| Kimyrsa | EXPERIMENTAL | A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimyrsa vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. |
| Name | Type | Description |
|---|---|---|
| Current Formulation of Oritavancin | DRUG | Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W) |
| Kimyrsa | DRUG | New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline) |
Inclusion Criteria: Subjects may be included in the study if they meet all of the following criteria: 1. Subject must be 18 years of age or older, male or female, and of any race. 2. Subject must give written informed consent before initiation of any study-related procedures. 3. Diagnosis of ABSSS...