A Single-center, Randomized, Double-blinded, 2-way Crossover, Placebo-controlled Study to Assess the QT/QTc Interval After Administration of Single Oral Dose of 400mg Moxifloxacin in Healthy Chinese Subjects

Peking University Third Hospital1 site in 1 country36 target enrollmentJuly 2012

ConditionsQT Interval Prolongation

Interventionsmoxifloxacin moxifloxacin-placebo

Drugsmoxifloxacin moxifloxacin-placebo

Overview

Phase: Not Applicable
Intervention: moxifloxacin
Conditions: QT Interval Prolongation
Sponsor: Peking University Third Hospital
Enrollment: 36
Locations: 1
Primary Endpoint: baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF)
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Principal Investigator

Haiyan Li

Director of Drug Clinical Trial Center

Peking University Third Hospital

Eligibility Criteria

Inclusion Criteria

•Healthy Chinese subjects, male, 20 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
•At Screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:
•Body temperature (Body) between 35.0-37.0°C
•90 ≤ systolic blood pressure \<140 mm Hg
•60≤ diastolic blood pressure \< 90 mm Hg
•50≤ pulse rate ≤ 100
•Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
•Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent prior to any screening procedures.

Exclusion Criteria

•History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
•A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of long QT syndrome, or QTc interval \> 440 ms for male or any abnormal ECG findings at screening.
•Medical histories of syncope, electrophysiological changes, heart failure, reduced exercise tolerance, cardiomyopathy, pericarditis, myocarditis or other cardiac disorders as determined by the investigator.
•Current electrolyte abnormalities (specifically hypokalemia) in laboratory examination during the screening that are clinical significant as determined by investigator.
•Current or recent history (\< 30 days prior to Screening) of a clinically significant illness.
•Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 4 week prior to initial dosing.
•Positive results of human immunodeficiency virus, Hepatitis B surface antigen or Hepatitis C antibody testing.
•History of any hypersensitivity or allergic reaction of moxifloxacin or other types fluoroquinolones.
•Use of tobacco or history of use of tobacco ( \> 5 tobacco/week) or nicotine-containing products in the 3 months prior to screening.
•History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.