The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Mary Birch Hospital for Women and Newborns
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
University of Louisville
Louisville, Kentucky, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Plasma concentration of dalbavancin
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Number of patients experiencing a treatment emergent adverse event
Time frame: Baseline (Day 1) up to Day 35
Maximum plasma drug concentration (Cmax)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent total body clearance (CL) of drug from plasma
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent volume of distribution volume of distribution (V)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Terminal elimination half-life (T1/2).
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
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Duke Medical Center
Durham, North Carolina, United States