NCT01449838 is a Phase 1 clinical trial of Colistimethate sodium in Infections, Pseudomonas, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01449838?

NCT01449838 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01449838?

Interventions in NCT01449838: Colistimethate sodium, Saline.

What condition does NCT01449838 study?

NCT01449838 studies Infections, Pseudomonas.

Is NCT01449838 still recruiting?

NCT01449838 is currently completed. Last updated 21 July 2017.

Last reviewed 2017-07-21 · How we verify

NCT01449838

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of Colistin Methanesulfonate Sodium

Completed Phase 1 Last updated 21 July 2017

What this trial tests

Phase 1 trial testing Colistimethate sodium in Infections, Pseudomonas in 22 participants. Completed in 9 December 2010.

Timeline

23 October 2010

Primary endpoint
9 December 2010

9 December 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	22
Start date	23 October 2010
Primary completion	9 December 2010
Estimated completion	9 December 2010
Sites	1 location across Australia

Drugs / interventions tested

Colistimethate sodium (COLISTIMETHATE SODIUM) — full drug profile →
Saline

Conditions studied

Infections, Pseudomonas — all drugs for Infections, Pseudomonas →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 55, male only, with Infections, Pseudomonas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and pharmacokinetic evaluation of intravenous colistin methanesulfonate sodium in Japanese healthy male subjects.
Mizuyachi K, Hara K, Wakamatsu A, Nohda S, et al · · 2011 · cited 26× · PMID 21995648 · DOI 10.1185/03007995.2011.626557

Verify or expand the search:

Other trials of Colistimethate sodium

Trials testing the same drug.

NCT01863719 — Aerosolized and Intravenous Colistin in Healthy Adults · Phase 1 · terminated

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01449838 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 21 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01449838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing