Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: tigecycline (Drug); tigecycline (Drug); moxifloxacin (Drug); 100 mL 0.9% Sodium Chloride intravenous (Drug); placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in
QT/QTc intervals.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Secondary outcome: QTc, using Fredericia's correction at each time point during moxifloxacin treatment periodsMaximum concentration pharmacokinetic endpoint for tigecycline Time of maximum concentration pharmacokinetic endpoint for tigecycline Elimination rate constant pharmacokinetic endpoint for tigecycline Half life pharmacokinetic endpoint for tigecycline Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline Clearance pharmacokinetic endpoint for tigecycline Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline Response-exposure relationships between QT/QTc and tigecycline concentration
Detailed description:
evaluation of effect of tigecycline on QT/QTc in healthy volunteers
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2011
Last updated: May 23, 2011
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