Moxifloxacin_QT Study in Chinese Healthy Volunteer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Peking University Third Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Haiyan Li, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01653990
First received: July 27, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
QT Interval Prolongation
Drug: moxifloxacin
Drug: moxifloxacin-placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate, PR, QRS, QTcB and QTcI [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: moxifloxacin, pill
Oral dose of 400mg moxifloxacin
Drug: moxifloxacin
oral dose of 400mg moxifloxacin
Drug: moxifloxacin-placebo
Oral dose of a pill of moxifloxacin-placebo
Placebo Comparator: moxifloxacin-placebo,pill
A pill of moxifloxacin-placebo
Drug: moxifloxacin
oral dose of 400mg moxifloxacin
Drug: moxifloxacin-placebo
Oral dose of a pill of moxifloxacin-placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.
  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: NCT01653990

Contacts
Contact: Jingchuan Guo, MD 861082265509 guojingchuan1029@126.com
Contact: Haiyan Li, MD 861082266226 haiyanli1027@hotmail.com

Locations
China
Peking University Third Hospital Drug Clinical Trial Center Recruiting
Beijing, China, 100191
Contact: Haiyan Li, MD    861082266226    haianli1027@hotmail.com   
Sub-Investigator: Jingchuan Guo, MD         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Principal Investigator: Haiyan Li, MD Peking University Third Hospital
  More Information

No publications provided

Responsible Party: Haiyan Li, Director of Drug Clinical Trial Center, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01653990     History of Changes
Other Study ID Numbers: DCTC_2012001
Study First Received: July 27, 2012
Last Updated: July 30, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Moxifloxacin
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