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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014