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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tigecycline; Drug: placebo; Drug: moxifloxacin; Drug: 100 mL 0.9% Sodium Chloride intravenous

• Registration Number: NCT01287793
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-23
• Last Update Posted: 2011-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high dose tigecycline	tigecycline	-
moxifloxacin	100 mL 0.9% Sodium Chloride intravenous	-
placebo	placebo	-
regular dose tigecycline	tigecycline	-
moxifloxacin	moxifloxacin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Elimination rate constant pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Half life pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods	-2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Clearance pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Response-exposure relationships between QT/QTc and tigecycline concentration	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States