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

Phase 1CompletedNCT01287793

Pfizer48 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

tigecyclineDRUG

intravenous, 200 mg, single dose

tigecyclineDRUG

intravenous, 50 mg, single dose

moxifloxacinDRUG

oral tablet, 400 mg, single dose

100 mL 0.9% Sodium Chloride intravenous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses

Time frame: Up to 96 hours