UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015502 |
|---|---|
| Receipt number | 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 11:01:11 |
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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
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
kuma-guy@za2.so-net.ne.jp
Sponsor or person
Institute
Kitasato University East Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018014
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
