Phase I Study of Colistin Methanesulfonate Sodium

Summary

This is a clinical study protocol for a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability and pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects. Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or placebo as a single dose and twice daily for 2.5 days by intravenous infusion. Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs), safety laboratory data, renal function and review of adverse events.

Timeline

Start

2010-10-23

Primary completion

2010-12-09

Completion

2010-12-09

Publications

• Results Mizuyachi K, Hara K, Wakamatsu A, Nohda S, Hirama T. Safety and pharmacokinetic evaluation of intravenous colistin methanesulfonate sodium in Japanese healthy male subjects. Curr Med Res Opin. 2011 Dec;27(12):2261-70. doi: 10.1185/03007995.2011.626557. Epub 2011 Oct 14.

Drugs

Indications