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

NCT01287793

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy

- Body mass index 17.5 - 30.5 kg

- Total body weight greater than 50 kg

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Recent history of diarrhea


- Use of oral antibiotics in the last 2 weeks


- History of risk factors for QT prolongation pregnant females


- Nursing females

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: tigecycline
    intravenous, 200 mg, single dose
    Other Name: Tygacil, GAR-936
  • Drug: tigecycline
    intravenous, 50 mg, single dose
    Other Name: Tygacil, GAR-936
  • Drug: moxifloxacin
    oral tablet, 400 mg, single dose
  • Drug: 100 mL 0.9% Sodium Chloride intravenous
    intravenous fluid, 100 mL, single dose
  • Drug: placebo
    0.9% Sodium Chloride intravenous 100mL, single dose
Study Arms  ICMJE
  • Experimental: high dose tigecycline
    Intervention: Drug: tigecycline
  • Experimental: regular dose tigecycline
    Intervention: Drug: tigecycline
  • Active Comparator: moxifloxacin
    Interventions:
    • Drug: moxifloxacin
    • Drug: 100 mL 0.9% Sodium Chloride intravenous
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 31, 2011)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01287793
Other Study ID Numbers  ICMJE B1811062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP