At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, PK and Safety Study to Evaluate the Relative Exposure and Safety of a New Formulation vs the Approved Formulation of a Single 1200 mg IV Dose of ORBACTIV® (Oritavancin) in Subjects Being Treated for ABSSSI
In Brief
A Phase 1 clinical trial evaluating Current Formulation of Oritavancin and Kimyrsa for Acute Bacterial Skin and Skin Structure Infection. Completed, enrolled 102 participants across 4 sites.
Detailed Summary
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
Study Details
Timeline
Interventions
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)