Status:
COMPLETED
A Study To Assess The Effect Of Linezolid On QTc Interval
Lead Sponsor:
Pfizer
Conditions:
Bacterial Infections
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00795145
Start Date
December 1 2008
End Date
March 1 2009
Last Update
June 22 2010
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770