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Completed

NCT Number: NCT01287793

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tigecycline

Drug

intravenous, 200 mg, single dose

Other names: Tygacil, GAR-936

moxifloxacin

Drug

oral tablet, 400 mg, single dose

100 mL 0.9% Sodium Chloride intravenous

Drug

intravenous fluid, 100 mL, single dose

Placebo

Drug

0.9% Sodium Chloride intravenous 100mL, single dose

Primary outcomes

  1. Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses

    Time frame: Up to 96 hours

Secondary outcomes

  1. QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods

    Time frame: -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

    Time frame: -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

    Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

  4. Elimination rate constant pharmacokinetic endpoint for tigecycline

    Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

  5. Half life pharmacokinetic endpoint for tigecycline

    Time frame: -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

    Time frame: -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

    Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

  8. Clearance pharmacokinetic endpoint for tigecycline

    Time frame: -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

    Time frame: -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

    Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2011
Registry last updated
May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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