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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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

NCT01287793
Pfizer
Completed
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

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Similar Trials

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.
evaluation of effect of tigecycline on QT/QTc in healthy volunteers
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • 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
  • 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
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.
 
Completed
48
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01287793
B1811062
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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