A Study To Assess The Effect Of Linezolid On QTc Interval
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Normal Healthy Volunteers
Intervention: Placebo (Drug); Linezolid 900 mg (Drug); Linezolid 1200 mg (Drug); Placebo (Drug); Linezolid 600 mg (Drug); Linezolid 1200 mg (Drug); Moxifloxacin 400 mg (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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
Study design: Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Cohort 2: Assessment of the effect on QT intervalCohort 1: Assessment of safety and tolerability
Secondary outcome: Cohort 1: Safety and PharmacokineticsCohort 2: QT interval, Pharmacokinetics, and Safety
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Singapore 188770, Singapore; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2009
Ending date: March 2009
Last updated: January 27, 2009
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