CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
Placebo +6 moredrug
Likely dose
Linezolid 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00795145
NCT00795145Phase 1Completed
CompareCT.gov

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

Pfizer·interventional·Posted Nov 21, 2008·Updated Jun 22, 2010

In Brief

A Phase 1 clinical trial evaluating Placebo, Linezolid 900 mg, and 3 other interventions for Bacterial Infections. Completed, enrolled 49 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infections
CountriesSingapore
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2008
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.6 years ago

Interventions

Placebodrug

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Linezolid 900 mgdrug

Intravenous, 900 mg linezolid, single dose

Linezolid 1200 mgdrug

Intravenous, 1200 mg linezolid, single dose

Placebodrug

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Linezolid 600 mgdrug

Intravenous, 600 mg linezolid, single dose

Linezolid 1200 mgdrug

Intravenous, 1200 mg linezolid, single dose

Moxifloxacin 400 mgdrug

Oral, 400 mg moxifloxacin, single dose