Phase 1
N=9
A Study To Assess The Effect Of Linezolid On QTc Interval
Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT00795145 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 1; 3; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Linezolid 900 mg (Drug); Linezolid 1200 mg (Drug); Linezolid 600 mg (Drug); Moxifloxacin 400 mg (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
1; 3; 2; 0; 0; 0 | — |
| PRIMARY 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 |
421.31; 422.34; 419.84; 419.71; 420.89; 422.67 | — |
| SECONDARY 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) |
223.49; 346.89; 211.26; 332.26 | — |
| SECONDARY Cohort 1: Maximum Observed Plasma Concentration (Cmax) |
22.3; 29.37 | — |
| SECONDARY Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2) |
1.0; 1.0; 6.9; 7.1 | — |
| SECONDARY Cohort 1: Clearance of Linezolid (CL) |
1.0173; 0.8813 | — |
| SECONDARY Cohort 1: Steady-State Volume of Distribution (Vss) |
0.6016; 0.5776 | — |
| SECONDARY Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo |
423.11; 419.84; 429.50; 422.67; 430.07; 419.80 | — |
| SECONDARY Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo |
424.08; 422.60; 420.60; 422.25; 414.80; 410.06 | — |
| SECONDARY Cohort 2: AUC Inf and AUC Last |
141.75; 328.75; 129.52; 299.40 | — |
| SECONDARY Cohort 2: Cmax |
15.06; 30.76 | — |
| SECONDARY Cohort 2: Tmax and t1/2 |
1.083; 1.1; 6.095; 6.796 | — |
| SECONDARY Cohort 2: CL |
1.2825; 1.1000 | — |
| SECONDARY Cohort 2: Vss |
0.6418; 0.6185 | — |
| SECONDARY Cohort 2: Number of Subjects With AEs and SAEs |
3; 7; 4; 10; 0; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00795145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.