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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01287793
First received: January 21, 2011
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: tigecycline
Drug: moxifloxacin
Drug: 100 mL 0.9% Sodium Chloride intravenous
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses [ Time Frame: Up to 96 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Maximum concentration pharmacokinetic endpoint for tigecycline [ Time Frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Half life pharmacokinetic endpoint for tigecycline [ Time Frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clearance pharmacokinetic endpoint for tigecycline [ Time Frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high dose tigecycline Drug: tigecycline
intravenous, 200 mg, single dose
Other Name: Tygacil, GAR-936
Experimental: regular dose tigecycline Drug: tigecycline
intravenous, 50 mg, single dose
Other Name: 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287793

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01287793     History of Changes
Other Study ID Numbers: B1811062
Study First Received: January 21, 2011
Last Updated: May 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Tigecycline
Minocycline
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013