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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01287793
Collaborator
(none)
48
Enrollment
1
Location
4
Arms
3.9
Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
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 Start Date :
Jan 1, 2011
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: high dose tigecycline

Drug: tigecycline
intravenous, 200 mg, single dose
Other Names:
  • Tygacil, GAR-936

    		•
    Experimental: regular dose tigecycline

    Drug: tigecycline
    intravenous, 50 mg, single dose
    Other Names:
  • Tygacil, GAR-936

    		•
    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
    Placebo Comparator: placebo

    Drug: placebo
    0.9% Sodium Chloride intravenous 100mL, single dose

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Maximum concentration pharmacokinetic endpoint for tigecycline [-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours]

    3. Time of maximum concentration pharmacokinetic endpoint for tigecycline [-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours]

    4. Elimination rate constant pharmacokinetic endpoint for tigecycline [-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours]

    5. Half life pharmacokinetic endpoint for tigecycline [-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours]

    6. 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]

    7. 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]

    8. Clearance pharmacokinetic endpoint for tigecycline [-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours]

    9. 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]

    10. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01287793
    Other Study ID Numbers:
    • B1811062
    First Posted:
    Feb 1, 2011
    Last Update Posted:
    May 24, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Moxifloxacin
    Tigecycline

    Study Results

    No Results Posted as of May 24, 2011