The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
Oritavancin has been approved in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. This is a Phase I, single center, double-blind, study evaluating the PK and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
56
IV - Single dose 1200 mg Oritavancin
D5W 5% in Water
Spaulding Clinical
West Bend, Wisconsin, United States
Safety & Tolerability: AEs/SAEs
A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing
Time frame: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: clinical safety laboratory results
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
Time frame: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: vital sign measurements
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
Time frame: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: ECGs
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
Time frame: From Consent up to 14 days following termination of the study drug infusion.
Safety & Tolerability: physical examination findings
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
Time frame: From Consent up to 14 days following termination of the study drug infusion.
PK parameters: Cmax and area under the plasma concentration-time curve
maximum measured plasma concentration
Time frame: From pre-dose until 168 hours from last dose
PK parameters: AUC
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AUC from time zero to the time of the last measurable concentration
Time frame: From pre-dose until 168 hours from last dose
PK parameters: t1/2
elimination half life
Time frame: From pre-dose until 168 hours from last dose
PK parameters: volume of distribution [Vz] and CL]
Volume of distribution
Time frame: From pre-dose to 168 hours from last dose
PK parameters: tmax
Time to Cmax
Time frame: From pre-dose to 168 hours from last dose