A Study To Assess The Effect Of Linezolid On QTc Interval
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
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: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo
Secondary outcome: Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)Cohort 1: Maximum Observed Plasma Concentration (Cmax) Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2) Cohort 1: Clearance of Linezolid (CL) Cohort 1: Steady-State Volume of Distribution (Vss) Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo Cohort 2: AUC Inf and AUC Last Cohort 2: Cmax Cohort 2: Tmax and t1/2 Cohort 2: CL Cohort 2: Vss Cohort 2: Number of Subjects With AEs and SAEs
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 Investigational Site, Singapore 188770, Singapore
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2008
Last updated: May 17, 2010
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