Conditions: Bacterial Infections
Keywords: Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 49
Healthy volunteers: yes

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 requirement.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: Placebo intervention 2: Linezolid 900 mg intervention 3: Linezolid 1200 mg intervention 4: Placebo intervention 5: Linezolid 600 mg intervention 6: Linezolid 1200 mg intervention 7: Moxifloxacin 400 mg
Intervention descriptions: intervention 1: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 2: Intravenous, 900 mg linezolid, single dose intervention 3: Intravenous, 1200 mg linezolid, single dose intervention 4: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 5: Intravenous, 600 mg linezolid, single dose intervention 6: Intravenous, 1200 mg linezolid, single dose intervention 7: Oral, 400 mg moxifloxacin, single dose

Protocol document: