A Study To Assess The Effect Of Linezolid On QTc Interval

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Fluoroquinolones; Linezolid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.