A Study To Assess The Effect Of Linezolid On QTc Interval - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00795145

Purpose

The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.

Condition	Intervention	Phase
Normal Healthy Volunteers	Drug: Placebo Drug: Linezolid 900 mg Drug: Linezolid 1200 mg Drug: Linezolid 600 mg Drug: Moxifloxacin 400 mg	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Single Dose Safety, Tolerability And Pharmacokinetics Of Escalating Intravenous Doses Of Linezolid Followed By Evaluation Of The Effect Of Single Intravenous Doses Of Linezolid On QTc Interval In Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Linezolid Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Cohort 1: Assessment of safety and tolerability [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
Cohort 2: Assessment of the effect on QT interval [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cohort 1: Safety and Pharmacokinetics [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
Cohort 2: QT interval, Pharmacokinetics, and Safety [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	December 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Placebo: Placebo Comparator	Drug: Placebo Intravenous, Placebo control for blinding, Normal Saline, Single dose
Cohort 1: 900 mg linezolid: Experimental	Drug: Linezolid 900 mg Intravenous, 900 mg linezolid, single dose
Cohort 1: 1200 mg linezolid: Experimental	Drug: Linezolid 1200 mg Intravenous, 1200 mg linezolid, single dose
Cohort 2: Placebo: Placebo Comparator	Drug: Placebo Intravenous, Placebo control for blinding, Normal Saline, Single dose
Cohort 2: 600 mg linezolid: Experimental	Drug: Linezolid 600 mg Intravenous, 600 mg linezolid, single dose
Cohort 2: 1200 mg linezolid: Experimental	Drug: Linezolid 1200 mg Intravenous, 1200 mg linezolid, single dose
Cohort 2: 400 mg Moxifloxacin: Active Comparator	Drug: Moxifloxacin 400 mg Oral, 400 mg moxifloxacin, single dose

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages of 21 and 55 years.
Body mass Index (BMI) of 18 to 30 kg/m2; and a total body weight > 45 kg (99 lbs).
An informed consent document signed and dated.

Exclusion Criteria:

Evidence or history of clinically significant abnormality.
12-lead ECG demonstrating QTc >450 msec at Screening.
Receiving selective serotonin reuptake inhibitors (SSRIs) and/or sympathomimetic agents.
Abnormal liver function tests.
A positive urine drug screen, history of excessive alcohol and tobacco use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795145

Locations

Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5951151
Study First Received:	November 20, 2008
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00795145 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Moxifloxacin

Therapeutic Uses
Enzyme Inhibitors
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009