NDLI: Pharmacokinetics, Safety, and Tolerability of a Single 500-mg or 1000-mg Intravenous Dose of Dalbavancin in Healthy Japanese Subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Scoble, Patrick J. Owens, Robert C. Puttagunta, Sailaja Yen, Mark Dunne, Michael W.
Description	Country affiliation: United States Author Affiliation: Scoble PJ ( Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA.); Owens RC ( Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA.); Puttagunta S ( Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA.); Yen M ( Parexel International, Early Phase Clinical Unit-Los Angeles, 1560 Chevy Chase Drive, Suite 140, Glendale, CA, 91206, USA.); Dunne MW ( Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA. Michael.w.dunne@comcast.net.)
Abstract	BACKGROUND AND OBJECTIVES: Dalbavancin is a novel, once-weekly glycopeptide antibiotic approved for treatment of acute bacterial skin infections. Given the importance of understanding any pharmacokinetic variability across different patient populations, a double-blind, placebo-controlled study was conducted to evaluate the pharmacokinetics, safety, and tolerability of a single 500-mg and a single 1000-mg intravenous dose of dalbavancin in healthy Japanese subjects. METHODS: Ten subjects received intravenous dalbavancin 1000 mg, five subjects received intravenous dalbavancin 500 mg, and three subjects received intravenous placebo. RESULTS: After a single infusion of dalbavancin, the maximal plasma concentration (C max) and area under the plasma concentration-time curve (AUC) increased in a proportional manner from 500 mg to 1000 mg (C max: 157 µg/ml and 299 µg/ml; AUClast: 10,850 µg·h/ml and 22,679 µg·h/ml, on the 500-mg and 1000-mg regimens, respectively) with low inter-subject variability. The mean terminal phase half-life (t 1/2) was 204 and 193 h after the 500-mg and 1000-mg dose, respectively. Clearance and volume of distribution were similar for the two dose concentrations. Treatment-emergent adverse events reported were considered to be of mild intensity. There were no relevant changes in laboratory values or vital signs over time in subjects in either treatment group. CONCLUSIONS: Overall, dalbavancin 500 mg and dalbavancin 1000 mg, administered as a single 30-min infusion, was well tolerated in this population and resulted in plasma exposures similar to those in non-Asians.
File Format	HTM / HTML
ISSN	11732563
e-ISSN	11791918
DOI	10.1007/s40261-015-0340-4
Journal	Clinical Drug Investigation
Issue Number	12
Volume Number	35
Language	English
Publisher	Springer
Publisher Date	2015-12-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	Open
Subject Keyword	Discipline Pharmacology Anti-bacterial Agents Administration & Dosage Pharmacokinetics Asian Continental Ancestry Group Teicoplanin Analogs & Derivatives Administration, Intravenous Adverse Effects Area Under Curve Double-blind Method Exanthema Chemically Induced Diagnosis Half-life Infusions, Intravenous Controlled Clinical Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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