Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
NCT ID: NCT01287793
Last Updated: 2011-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-01-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects
NCT01325415
A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
NCT05878522
A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers
NCT03164109
Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers
NCT02293148
A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
NCT00926263
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
high dose tigecycline
tigecycline
intravenous, 200 mg, single dose
regular dose tigecycline
tigecycline
intravenous, 50 mg, single dose
moxifloxacin
moxifloxacin
oral tablet, 400 mg, single dose
100 mL 0.9% Sodium Chloride intravenous
intravenous fluid, 100 mL, single dose
placebo
placebo
0.9% Sodium Chloride intravenous 100mL, single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tigecycline
intravenous, 200 mg, single dose
tigecycline
intravenous, 50 mg, single dose
moxifloxacin
oral tablet, 400 mg, single dose
100 mL 0.9% Sodium Chloride intravenous
intravenous fluid, 100 mL, single dose
placebo
0.9% Sodium Chloride intravenous 100mL, single dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index 17.5 - 30.5 kg
* Total body weight greater than 50 kg
Exclusion Criteria
* Use of oral antibiotics in the last 2 weeks
* History of risk factors for QT prolongation pregnant females
* Nursing females
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1811062
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.