This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
Single IV dose oritavancin (1200 mg) has been approved in the U.S. for the treatment of adult patients with ABSSSI caused or suspected to be caused by Gram-positive microorganisms. The current study is being conducted to evaluate the relative exposure, PK and safety of a new formulation of oritavancin, Kimyrsa, by adjusting infusion time, concentration and reconstitution/administration solutions of a single 1200 mg IV infusion of oritavancin in adult subjects with ABSSSI. Fifty (50) subjects will be administered the currently approved formulation of oritavancin, using the approved dosing regimen in which Sterile Water for Injection (SWFI) is the reconstituting agent and Dextrose 5% in Water (D5W) is used for further dilution to a total volume of 1000 mL. This formulation will be infused per the approved label over 3 hours. An additional 50 subjects will be administered Kimyrsa which contains hydroxypropyl-β-cyclodextrin (HPβCD). This formulation will be reconstituted with SWFI and further diluted in 0.9% sodium chloride (saline) to a total volume of 250 mL. This formulation will be infused over 60 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
102
Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)
New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)
ML-ORI-102 Study Site
Chula Vista, California, United States
ML-ORI-102 Study Site
La Mesa, California, United States
ML-ORI-102 Study Site
Burr Ridge, Illinois, United States
ML-ORI-102 Study Site
Somers Point, New Jersey, United States
Relative Exposure of AUC of the New Formulation to the Approved Formulation
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)
Time frame: 72 hours
Relative Exposure of AUC of the New Formulation to the Approved Formulation
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 168 hr (AUC0-168).
Time frame: 168 hours (Day 8)
Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE)
Number of subjects with at least one treatment emergent adverse event (TEAE)
Time frame: 336 hours (Day 15)
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