Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tigecycline; Drug: 100 mL 0.9% Sodium Chloride intravenous; Drug: placebo; Drug: moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287793

B1811062

Details and patient eligibility

About

Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.

Full description

evaluation of effect of tigecycline on QT/QTc in healthy volunteers

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Body mass index 17.5 - 30.5 kg
• Total body weight greater than 50 kg

Exclusion criteria

• Recent history of diarrhea
• Use of oral antibiotics in the last 2 weeks
• History of risk factors for QT prolongation pregnant females
• Nursing females

Trial design

48 participants in 4 patient groups, including a placebo group

high dose tigecycline

Experimental group

Treatment:

Drug: tigecycline

Drug: tigecycline

regular dose tigecycline

Experimental group

Treatment:

Drug: tigecycline

Drug: tigecycline

moxifloxacin

Active Comparator group

Treatment:

Drug: moxifloxacin

Drug: 100 mL 0.9% Sodium Chloride intravenous

placebo

Placebo Comparator group

Treatment:

Drug: placebo