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

Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tigecycline; Drug: tigecycline; Drug: moxifloxacin; Drug: 100 mL 0.9% Sodium Chloride intravenous; Drug: placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; 0.9% Sodium Chloride intravenous 100mL, single dose
Active Comparator: moxifloxacin	Drug: moxifloxacin; oral tablet, 400 mg, single dose; Drug: 100 mL 0.9% Sodium Chloride intravenous; intravenous fluid, 100 mL, single dose
Experimental: high dose tigecycline	Drug: tigecycline; intravenous, 200 mg, single dose; Other Names: Tygacil, GAR-936; Drug: tigecycline; intravenous, 50 mg, single dose; Other Names: Tygacil, GAR-936
Experimental: regular dose tigecycline	Drug: tigecycline; intravenous, 200 mg, single dose; Other Names: Tygacil, GAR-936; Drug: tigecycline; intravenous, 50 mg, single dose; Other Names: Tygacil, GAR-936

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Korth-Bradley JM, McGovern PC, Salageanu J, Matschke K, Plotka A, Pawlak S. Tigecycline does not prolong corrected QT intervals in healthy subjects. Antimicrob Agents Chemother. 2013 Apr;57(4):1895-901. doi: 10.1128/AAC.01576-12. Epub 2013 Feb 12.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 24, 2011
• Last Update Submitted That Met QC Criteria: May 23, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Moxifloxacin; Tigecycline
• Other Study ID Numbers: B1811062