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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015502
Receipt No. R000018014
Scientific Title A Single-dose, Randomized, Placebo-controlled, Two-period Crossover Study of the Effects of Moxifloxacin on the ECG Intervals in Healthy Japanese and Caucasian Subjects at Two Sites: Focus on the Role of Ethnicity on Cardiac Repolarization
Date of disclosure of the study information 2014/10/23
Last modified on 2015/06/18

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Basic information
Public title A Single-dose, Randomized, Placebo-controlled, Two-period Crossover Study of the Effects of Moxifloxacin on the ECG Intervals in Healthy Japanese and Caucasian Subjects at Two Sites: Focus on the Role of Ethnicity on Cardiac Repolarization
Acronym QT-E1
Scientific Title A Single-dose, Randomized, Placebo-controlled, Two-period Crossover Study of the Effects of Moxifloxacin on the ECG Intervals in Healthy Japanese and Caucasian Subjects at Two Sites: Focus on the Role of Ethnicity on Cardiac Repolarization
Scientific Title:Acronym QT-E1
Region
Japan North America

Condition
Condition healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this trial is to assess the ECG effects of moxifloxacin 400 mg relative to placebo following single dose administration in healthy adult male Caucasian and Japanese subjects to determine if ethnic differences exist on the QTc interval (Similarity margin: +-5ms at the Cmax of moxi (ddQTc ~10ms)
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To compare the time matched difference of delta-delta QTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Japanese and Caucasian subjects under the same exposure ( Cmax ) of Moxifloxacin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 moxifloxacin 400 mg
Interventions/Control_2 placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
45 years-old >=
Gender Male
Key inclusion criteria A subject is considered eligible for participation in the trial if the following inclusion criteria are satisfied at the screening visit or at baseline:
1. Healthy males between the ages of 18 and 45 years at the time of Screening
2. Body weight between 50-100 kg and body mass index (BMI) within 18-28 kg/m2 at screening
3. Current non-smokers who have not used any nicotine-containing products (chewed or smoked) in the year prior to screening.
4. Willing to communicate with the investigator and site staff and comply with all study procedures and requirements;
5. Able to provide written, informed consent including compliance with the requirements listed in the consent form.
Key exclusion criteria 1.Past or present diseases, which as judged by the investigator, may affect the outcome of this study, include, but not limited to, significant medical abnormality including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic, or autoimmune disorder
2. Positive for HIV, hepatitis B and/or hepatitis C at screening
3. Family history of QTc prolongation or of unexplainable sudden death at <50 years of age
4. Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders
5. Any condition that may interfere with the absorption, metabolism, or elimination of the study drug
6. History of, or active, alcohol or illicit drug abuse. Alcohol abuse is defined as an average intake of three or more drinks (12 oz beer, 1.5 oz of hard liquor, or equivalent) per day
7. Tobacco use (chewed or smoked) unless abstinent for at least one month
8. Laboratory safety test results that are outside of the normal reference ranges (unless clinically acceptable to the Principal Investigator) or are clinically significant abnormalities as determined by the Principal Investigator
9. At screening: resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute (may be repeated once at the discretion of the Investigator). Minor deviations will be acceptable if considered to be of no clinical significance by the Investigator.
10. At screening: resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg. Blood pressure measurements may be repeated once at the discretion of the Investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Kumagai
Organization Kitasato University East Hospital
Division name Clinical Research Center
Zip code
Address 2-1-1, Asamizo-dai Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
TEL +81-42-748-9111
Email kuma-guy@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Kumagai
Organization Kitasato University East Hospital
Division name Clinical Research Center
Zip code
Address 2-1-1, Asamizo-dai Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
TEL +81-42-748-9111
Homepage URL
Email kuma-guy@za2.so-net.ne.jp

Sponsor
Institute Kitasato University East Hospital
Institute
Department

Funding Source
Organization Kitasato University Clinical Trial Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北里大学東病院(神奈川県)(Kitasato University East Hospital,Kanagawa)

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 15 Day
Last follow-up date
2014 Year 06 Month 29 Day
Date of closure to data entry
2014 Year 07 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 22 Day
Last modified on
2015 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018014

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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