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Status unknownNCT01653990Updated Jul 31, 2012

Moxifloxacin_QT Study in Chinese Healthy Volunteer

An interventional study of moxifloxacin and moxifloxacin-placebo in QT Interval Prolongation, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-31.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • QT Interval Prolongation
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. 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
  3. Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
  4. 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

Exclusion Criteria:

  1. History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
  2. 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.
  3. Medical histories of syncope, electrophysiological changes, heart failure, reduced exercise tolerance, cardiomyopathy, pericarditis, myocarditis or other cardiac disorders as determined by the investigator.
  4. Current electrolyte abnormalities (specifically hypokalemia) in laboratory examination during the screening that are clinical significant as determined by investigator.
  5. Current or recent history (\< 30 days prior to Screening) of a clinically significant illness.
  6. 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.
  7. Positive results of human immunodeficiency virus, Hepatitis B surface antigen or Hepatitis C antibody testing.
  8. History of any hypersensitivity or allergic reaction of moxifloxacin or other types fluoroquinolones.
  9. Use of tobacco or history of use of tobacco ( > 5 tobacco/week) or nicotine-containing products in the 3 months prior to screening.
  10. 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.
  11. Dosing of study drug in any clinical investigation within 3 months prior to initial dosing.
  12. Donation or loss of 200 ml or more of blood within 3 months prior to participation, or donation of component blood within 3 months prior to participation.
  13. Consumption of alcohol-, caffeine --containing foods or beverages within 48 hours preceding study drug administration.
  14. Other conditions which investigator deems potential harm to subjects if participate the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    moxifloxacin, pill

    Oral dose of 400mg moxifloxacin

    Drug: moxifloxacin · Drug: moxifloxacin-placebo

  • Placebo comparator
    moxifloxacin-placebo,pill

    A pill of moxifloxacin-placebo

    Drug: moxifloxacin · Drug: moxifloxacin-placebo

Interventions

  • Drugmoxifloxacin

    oral dose of 400mg moxifloxacin

  • Drugmoxifloxacin-placebo

    Oral dose of a pill of moxifloxacin-placebo

06

What researchers measure

Primary outcomes

  1. baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF)

    Time frame: 1 month

Secondary outcomes

  1. Heart rate, PR, QRS, QTcB and QTcI

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital Drug Clinical Trial Center
    Beijing, 100191, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01653990
Lead sponsor
Peking University Third Hospital
Responsible party
Haiyan Li (Director of Drug Clinical Trial Center, Peking University Third Hospital) — Principal investigator
First posted
Jul 31, 2012
Start date
Jul 2012
Primary completion
Sep 2012 (estimated)
Completion
Oct 2012 (estimated)
Last update
Jul 31, 2012

Study contacts

Jingchuan Guo, MD
Contact
guojingchuan1029@126.com
861082265509
Haiyan Li, MD
Contact
haiyanli1027@hotmail.com
861082266226
Haiyan Li, MD
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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